The recommendations in this draft guidance are consistent with “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]” guidance, and provide additional ...May 31, 2016 ... This Video will show an understanding of how to get a device requiring a 510(k) submission to market quickly ... 510(k) ... Premarket Approval (PMA) ...Date Received: 11/30/2021: Decision Date: 04/03/2023: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Dental 510k Review PanelThe information I agree to make available will be a duplicate of the premarket notification submission, including any adverse safety and effectiveness information, but excluding all patient ...510(k) Premarket Notification. FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Registration & Listing | Adverse Events ... Medsun Reports | CLIA | TPLC : New Search: Back To Search Results: Device Classification Name: diabetic retinopathy detection device: 510(k) Number: K221183: Device Name: AEYE-DS: Applicant: AEYE …Date Received: 04/05/2016: Decision Date: 08/26/2016: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Physical Medicine 510k Review Panel510 (k) Number. K222813. Device Name. Nitrile Examination Gloves. Applicant. Ecoglove Medical Manufacturing Company Limited. A Part of Land plot No. 679, map No. 41, N4 Street, Bau Bang Hamlet. Lai Uyen Town, Bau Bang District, VN.Date Received: 08/04/2023: Decision Date: 09/01/2023: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Physical Medicine 510k Review PanelDevice Classification Name: multi-target respiratory specimen nucleic acid test including sars-cov-2 and other microbial agents: 510(k) Number: K213954510 (K) Premarket Notification. A 510 (K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and …Mar 4, 2024 · Date Received: 06/01/2021: Decision Date: 11/30/2021: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Cardiovascular 510(k) Premarket Notification. FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Registration & Listing | Adverse Events ... Back To Search Results: Device Classification Name: high intensity ultrasound system for prostate tissue ablation: 510(k) Number: K160942: Device Name: Sonablate: Applicant: SonaCare Medical, LLC: … photoplethysmograph analysis software for over-the-counter use. 22. 510 (k) Number. K213971. Device Name. Atrial Fibrillation History Feature. Applicant. Apple Inc. 1 Apple Park Way. Section 515C provides FDA with express authority to approve or clear predetermined change control plans (PCCPs) for devices requiring premarket …Feb 22, 2021 ... What are the various routes to US FDA device clearance / approval? The majority of medical devices are cleared for marketing in the U.S. by ...510(k) Premarket Notification. FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Registration & Listing | Adverse Events ... TPLC : New Search: Back To Search Results: Device Classification Name: system, imaging, pulsed doppler, ultrasonic: 510(k) Number: K231190: Device Name: EPIQ Series Diagnostic Ultrasound System: …radiological computer assisted detection/diagnosis software for lesions suspicious for cancer. 22. 510 (k) Number. K212783. Device Name. ProstatID. Applicant. ScanMed, LLC. 9840 S 140 Street, Suite #8.Mar 4, 2024 · 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. 1-888-INFO-FDA (1-888-463-6332) Contact FDA Date Received: 06/01/2021: Decision Date: 11/30/2021: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Cardiovascular 510k Review PanelPremarket Notification 510(k) submissions for medical devices are reviewed and processed by the Center for Devices and Radiological Health (CDRH) within the Food and Drug Administration (FDA).510(k) Premarket Notification. FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls ... New Search: Back To Search Results: Device Classification Name: catheter, percutaneous: 510(k) Number: K232437: Device Name: Paragon 8F Balloon Guide Catheter: Applicant: Wallaby Medical: 22901 Mill Creek ...Device Classification Name. software, similarity score algorithm, tissue of origin for malignant tumor types. 22. 510 (k) Number. K080896. Device Name. PATHWORK DIAGNOSTICS TISSUE OF ORIGIN TEST. Applicant. PATHWORK DIAGNOSTICS, INC.22. 510 (k) Number. K200983. Device Name. Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine. Applicant. Ningbo Hesi Electric Co., Ltd. No.818-23-156 Qiming Rd, Yinzhou, Ningbo City Zhejiistrict, Ningbo, Zhejiang,There are three types of Premarket Notification 510(k)s that may be submitted to the FDA: Traditional, Special, and Abbreviated. In 1998, the FDA developed both the Special and Abbreviated 510(k ...Date Received: 11/28/2022: Decision Date: 06/01/2023: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Radiology 510k Review Panel510(k) Premarket Notification. FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Registration & Listing | Adverse Events ... New Search: Back To Search Results: Device Classification Name: high flow/high velocity humidified oxygen delivery device: 510(k) Number: K221338: Device Name: F&P Airvo 3: Applicant: Fisher & Paykel …510 (k) Number. K173760. Device Name. Monarch Endoscopy Platform (Monarch Platform) Applicant. Auris Surgical Robotics, Inc. 125 Shoreway Road. Suite D. San Carlos, CA 94070.Date Received: 07/18/2022: Decision Date: 03/17/2023: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Neurology 510k Review PanelTelegram has become one of the most popular messaging platforms around the world, offering a range of features and functionality that make it a versatile tool for communication. An...510(k) Premarket Notification. FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Registration & Listing | Adverse Events ... TPLC : New Search: Back To Search Results: Device Classification Name: device, anti-snoring: 510(k) Number: K092942: Device Name: VITAL SLEEP: Applicant: THE SNORE RELIEVER COMPANY LLC: …Date Received: 08/03/2023: Decision Date: 03/01/2024: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: General HospitalDate Received: 08/04/2023: Decision Date: 09/01/2023: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Physical Medicine 510k Review Panel510(k) Premarket Notification. FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Registration & Listing | Adverse Events ... New Search: Back To Search Results: Device Classification Name: physiological signal based seizure monitoring system: 510(k) Number: K181861: Device Name: Embrace: Applicant: Empatica Srl: Via Stendhal …Mar 4, 2024 · 510 (k) Number. K222898. Device Name. SafeSource Direct Blue Powder-Free Nitrile Exam Gloves. Applicant. SafeSource Direct, LLC. 200 St Nazaire Rd. Broussard, LA 70518. Applicant Contact. Date Received: 09/21/2022: Decision Date: 09/22/2023: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Dental 510k Review PanelThe Guidance for Industry and Food and Drug Administration Staff: Refuse to Accept Policy for 510(k)s describes the criteria FDA intends to use in assessing whether a 510(k) submission meets a ...Types of FDA 510 (k) Premarket Notification. The 510k submission process. 510k Application Timeline. Sundeep Agarwal, medical device regulatory consultant on Kolabtree, …510(k) Premarket Notification. FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Registration & Listing | Adverse Events ... Back To Search Results: Device Classification Name: alternate controller enabled insulin infusion pump: 510(k) Number: K213536: Device Name: DEKA ACE Pump System: Applicant: DEKA Research …May 31, 2016 ... This Video will show an understanding of how to get a device requiring a 510(k) submission to market quickly ... 510(k) ... Premarket Approval (PMA) ...22. 510 (k) Number. K200983. Device Name. Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine. Applicant. Ningbo Hesi Electric Co., Ltd. No.818-23-156 Qiming Rd, Yinzhou, Ningbo City Zhejiistrict, Ningbo, Zhejiang,510(k) Premarket Notification. FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Registration & Listing | Adverse Events ... Back To Search Results: Device Classification Name: lenses, soft contact, daily wear: 510(k) Number: K180299: Device Name: ACUVUE OASYS (senofilcon A) with Photochromic Additive: Applicant: …Under section 524B(a) of the FD&C Act (21 U.S.C. 360n-2(a)), a person who submits a 510(k), premarket approval application (PMA), product …6 days ago · Date Received: 09/21/2022: Decision Date: 09/22/2023: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Dental 510 (k) Premarket Notification. Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services (Portrait CSS01), Portrait™ Clinical Alarming Unit (Portrait CAU01); Portrait™ Mobile Patient Monitor (Portrait HUB01), Portrait™ Sensor Battery (Portrait SBT01), Portrait™ Bedside Charger (Portrait BCH01); Portrait™ W.Premarket Notification 510 (k) searchable database. CFR search engine. The complete FDA Premarket Notification database is offered here in SAS, Stata, …There are three types of Premarket Notification 510 (k)s that may be submitted to the FDA: Traditional, Special, and Abbreviated. In 1998, the FDA …Section 515C provides FDA with express authority to approve or clear predetermined change control plans (PCCPs) for devices requiring premarket …510 (k) Premarket Notification. A 510 (K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and …6 days ago · 510 (k) Number. K231918. Device Name. Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter. Applicant. Date Received: 09/26/2022: Decision Date: 04/28/2023: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Radiology 510k Review PanelDevice Classification Name: system, nucleic acid amplification test, dna, carbapenem non-susceptible gram negative organism, colony: 510(k) NumberAccording to 21 CFR 807.81(a)(3), a premarket notification must be submitted when the device. is about to be significantly changed or modified in design, components, method of manufacture, or intended use. To further clarify the regulatory standard, significant changes include ... Unlike most FDA premarket review programs, the 510(k) process ...Are you in search of a reliable source for job notifications and exam results? Look no further than Sarkariresult.com. This website has become a go-to platform for individuals seek...extracorporeal system for long-term respiratory / cardiopulmonary failure. 22. 510 (k) Number. K191407. Device Name. Novalung System. Applicant. Fresenius Medical Care Renal Therapies Group, LLC. 920 Winter Street.Develop and direct strategic regulatory planning, creation, and revision of labeling for combination product and device submissions (pre and post …Device Classification Name: intervertebral fusion device with bone graft, lumbar: 510(k) Number: K231680: Device Name: AccelFix Lumbar Expandable Cage SystemAre you someone who is constantly on the lookout for government job opportunities? If so, then you must be familiar with the term “Sarkari Result.” In India, Sarkari Result has bec... Date Received: 12/23/2022: Decision Date: 10/13/2023: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Anesthesiology 510(k) Premarket Notification. FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA ... Device Classification Name: integrated continuous glucose monitoring system, factory calibrated: 510(k) Number: K213919: Device Name: Dexcom G7 Continuous Glucose Monitoring …510(k) Premarket Notification. FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Registration & Listing | Adverse Events ... Back To Search Results: Device Classification Name: microbial nucleic acid storage and stabilization device: 510(k) Number: K202641: Device Name: DNA/RNA Shield Collection Tube: Applicant: Zymo …Mar 28, 2022 ... Today Rob Packard recorded an updated version of the 2015 webinar about predicate selection. This is one of webinars that comprise Medical ...Are you in search of a reliable source for job notifications and exam results? Look no further than Sarkariresult.com. This website has become a go-to platform for individuals seek...10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. 1-888-INFO-FDA (1-888-463-6332) Contact FDAA 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval (PMA). 510(k) (premarket notification) to FDA is required at least 90 days before marketing unless the device is exempt from …Mar 4, 2024 · 510 (k) Number. K222898. Device Name. SafeSource Direct Blue Powder-Free Nitrile Exam Gloves. Applicant. SafeSource Direct, LLC. 200 St Nazaire Rd. Broussard, LA 70518. Applicant Contact. Premarket Notification 510(k) For Class I and II devices that are not exempt from premarket review or are not subject to another type of marketing submission. 510(k) Third Party Review Program.The Guidance for Industry and Food and Drug Administration Staff: Refuse to Accept Policy for 510(k)s describes the criteria FDA intends to use in assessing whether a 510(k) submission meets a ...Mar 4, 2024 · 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. 1-888-INFO-FDA (1-888-463-6332) Contact FDA 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. 1-888-INFO-FDA (1-888-463-6332) Contact FDAUnder section 524B(a) of the FD&C Act (21 U.S.C. 360n-2(a)), a person who submits a 510(k), premarket approval application (PMA), product …Date Received: 08/18/2023: Decision Date: 11/17/2023: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Cardiovascular 510k Review Panel510(k) Premarket Notification. FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA ... Device Classification Name: integrated continuous glucose monitoring system, factory calibrated: 510(k) Number: K213919: Device Name: Dexcom G7 Continuous Glucose Monitoring …Date Received: 05/28/2019: Decision Date: 01/24/2020: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Cardiovascular 510k Review Panel510(k) Premarket Notification. FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Registration & Listing | Adverse Events ... New Search: Back To Search Results: Device Classification Name: implant, endosseous, root-form: 510(k) Number: K230242: Device Name: OsteoCentric Dental Implant System: Applicant: OsteoCentric … A premarket notification (510(k)) is required when a legally marketed device subject to 510(k) requirements is significantly changed or modified in design, components, method of manufacture, or ... 510 (k) Number. K222898. Device Name. SafeSource Direct Blue Powder-Free Nitrile Exam Gloves. Applicant. SafeSource Direct, LLC. 200 St Nazaire Rd. Broussard, LA 70518. Applicant Contact.510(k) Premarket Notification. FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA ... Device Classification Name: integrated continuous glucose monitoring system, factory calibrated: 510(k) Number: K213919: Device Name: Dexcom G7 Continuous Glucose Monitoring …Device Classification Name. transcranial magnetic stimulation system for obsessive-compulsive disorder. 22. 510 (k) Number. K212289. Device Name. NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, …Date Received: 01/04/2021: Decision Date: 06/11/2021: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Neurology 510k Review Panel You can search the releasable 510(k) database by Panel, 510(k) number, Product code or Device name. ... FDA Continues to Take Steps to Strengthen the Premarket Notification [510(k)] Program ... 510(k) Premarket Notification. FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Registration & Listing | Adverse Events ... Back To Search Results: Device Classification Name: microbial nucleic acid storage and stabilization device: 510(k) Number: K202641: Device Name: DNA/RNA Shield Collection Tube: Applicant: Zymo …510 k premarket notification
510(k) Premarket Notification. FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Registration & Listing | Adverse Events ... Back To Search Results: Device Classification Name: alternate controller enabled insulin infusion pump: 510(k) Number: K213536: Device Name: DEKA ACE Pump System: Applicant: DEKA Research …Deeptek Medical Imaging Private Limited: 3rd floor, Ideas to impact, Pallod Farms 3, Baner: Pune, IN 411045Date Received: 03/31/2015: Decision Date: 09/03/2015: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Gastroenterology/UrologyIf your medical device is eligible under premarket notification criteria, there are three types of 510(k)s: Traditional, Abbreviated, and Special. …Date Received: 05/20/2022: Decision Date: 02/10/2023: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Obstetrics/Gynecology 510k Review PanelFeb 22, 2021 ... What are the various routes to US FDA device clearance / approval? The majority of medical devices are cleared for marketing in the U.S. by ...510(k) Premarket Notification. FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Registration & Listing | Adverse Events ... TPLC : New Search: Back To Search Results: Device Classification Name: thin layer chromatography, methamphetamine: 510(k) Number: K171403: Device Name: OralTox Oral Fluid Drug Test: Applicant: …510(k) Premarket Notification. FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Registration & Listing | Adverse Events ... TPLC : New Search: Back To Search Results: Device Classification Name: thin layer chromatography, methamphetamine: 510(k) Number: K171403: Device Name: OralTox Oral Fluid Drug Test: Applicant: …Date Received: 06/19/2017: Decision Date: 11/16/2017: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Cardiovascular 510k Review PanelEvery autumn, November 1 doesn’t just begin the countdown to the major winter holidays. It also signals the start of a critical financial time of year: open enrollment season. In m...Device Classification Name: apparatus, cutting, radiofrequency, electrosurgical, battery-powered: 510(k) Number: K050933: Device Name: FUGO BLADE FOR PERIPHERAL ... There are three types of Premarket Notification 510(k)s that may be submitted to the FDA: Traditional, Special, and Abbreviated. In 1998, the FDA developed both the Special and Abbreviated 510(k ... 510 (k) Number. K222898. Device Name. SafeSource Direct Blue Powder-Free Nitrile Exam Gloves. Applicant. SafeSource Direct, LLC. 200 St Nazaire Rd. Broussard, LA 70518. Applicant Contact.510(k) Premarket Notification. FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Registration & Listing | Adverse Events ... New Search: Back To Search Results: Device Classification Name: high flow/high velocity humidified oxygen delivery device: 510(k) Number: K221338: Device Name: F&P Airvo 3: Applicant: Fisher & …According to 21 CFR 807.81(a)(3), a premarket notification must be submitted when the device. is about to be significantly changed or modified in design, components, method of manufacture, or intended use. To further clarify the regulatory standard, significant changes include ... Unlike most FDA premarket review programs, the 510(k) process ...510(k) Premarket Notification. FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Registration & Listing | Adverse Events ... TPLC : New Search: Back To Search Results: Device Classification Name: system, multipurpose for in vitro coagulation studies: 510(k) Number: K233790: Device Name: ACL TOP 970 CL: Applicant: …510(k) Premarket Notification. FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Registration & Listing | Adverse Events ... TPLC : New Search: Back To Search Results: Device Classification Name: implant, eye valve: 510(k) Number: K220032: Device Name: iStent infinite Trabecular Micro-Bypass System, Model iS3: Applicant: …510(k) Premarket Notification. FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Registration & Listing | Adverse Events ... TPLC : New Search: Back To Search Results: Device Classification Name: device, anti-snoring: 510(k) Number: K092942: Device Name: VITAL SLEEP: Applicant: THE SNORE RELIEVER COMPANY LLC: …premarket approval applications (PMAs) under section 515 of the FD&C Act (21 U.S.C. 360e) or premarket notification under section 510(k) of the FD&C …6 days ago · 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. 1-888-INFO-FDA (1-888-463-6332) Contact FDA 6 days ago · 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. 1-888-INFO-FDA (1-888-463-6332) Contact FDA Date Received: 07/13/2023: Decision Date: 12/08/2023: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Dental 510k Review PanelOct 3, 2022 · Premarket Notification 510(k) For Class I and II devices that are not exempt from premarket review or are not subject to another type of marketing submission. 510(k) Third Party Review Program. Mar 4, 2024 · system, imaging, pulsed doppler, ultrasonic. 22. 510 (k) Number. K222648. Device Name. 5000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500 P, Ultrasound System 5500 W, Ultrasound System 5500 CV, Ultrasound System 5300 G, Ultrasound System 5300 P, Ultrasound System 5300 W) Applicant. Philips Ultrasound LLC. Date Received: 08/17/2020: Decision Date: 12/10/2020: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Neurology Date Received: 03/31/2015: Decision Date: 09/03/2015: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Gastroenterology/Urology6 days ago · Date Received: 05/30/2023: Decision Date: 02/02/2024: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Gastroenterology/Urology premarket approval applications (PMAs) under section 515 of the FD&C Act (21 U.S.C. 360e) or premarket notification under section 510(k) of the FD&C …510(k) Premarket Notification. FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Registration & Listing | Adverse Events ... TPLC : New Search: Back To Search Results: Device Classification Name: thin layer chromatography, methamphetamine: 510(k) Number: K171403: Device Name: OralTox Oral Fluid Drug Test: Applicant: …Deciding when to submit a 510 (k) is not always about brand-new, first-time-to-market medical devices, either. In certain circumstances, an existing, already marketed device might require a fresh 510 (k) submission. As we can see, the 'traditional' and 'special' routes are both 510 (k) pathways open for medical devices already on the market.Device Classification Name: system, image processing, radiological: 510(k) Number: K211257: Device Name: EFAI PACS Picture Archiving and Communication SystemIn today’s fast-paced digital world, businesses are constantly looking for ways to stay connected with their audience and drive engagement. One effective tool that has gained signi...Mar 4, 2024 · 510 (k) Number. K222898. Device Name. SafeSource Direct Blue Powder-Free Nitrile Exam Gloves. Applicant. SafeSource Direct, LLC. 200 St Nazaire Rd. Broussard, LA 70518. Applicant Contact. Mar 4, 2024 · system, imaging, pulsed doppler, ultrasonic. 22. 510 (k) Number. K222648. Device Name. 5000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500 P, Ultrasound System 5500 W, Ultrasound System 5500 CV, Ultrasound System 5300 G, Ultrasound System 5300 P, Ultrasound System 5300 W) Applicant. Philips Ultrasound LLC. 510 (k) Number. K063023. Device Name. 3M HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1870. Applicant. 3M COMPANY. 3M CENTER BUILDING 275-05W-06. ST. PAUL, MN 55144. There are three types of Premarket Notification 510(k)s that may be submitted to the FDA: Traditional, Special, and Abbreviated. In 1998, the FDA developed both the Special and Abbreviated 510(k ... Device Classification Name: system, image processing, radiological: 510(k) Number: K211257: Device Name: EFAI PACS Picture Archiving and Communication SystemSee full list on fda.gov 510(k) Premarket Notification. FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Registration & Listing | Adverse Events ... New Search: Back To Search Results: Device Classification Name: high flow/high velocity humidified oxygen delivery device: 510(k) Number: K221338: Device Name: F&P Airvo 3: Applicant: Fisher & Paykel …510(k) Premarket Notification. FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Registration & Listing | Adverse Events ... Back To Search Results: Device Classification Name: lenses, soft contact, daily wear: 510(k) Number: K180299: Device Name: ACUVUE OASYS (senofilcon A) with Photochromic Additive: Applicant: …510 (k) Number. K221895. Device Name. Terumo Advanced Perfusion System 1. Applicant. Terumo Cardiovascular Systems Corporation. 6200 Jackson Road. Ann Arbor, MI 48103. Applicant Contact.Mar 4, 2024 · Date Received: 05/28/2019: Decision Date: 01/24/2020: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Cardiovascular 510(k) Premarket Notification. FDA Home; Medical Devices; Databases - 510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls ... New Search: Back To Search Results: Device Classification Name: catheter, percutaneous: 510(k) Number: K232437: Device Name: Paragon 8F Balloon Guide Catheter: Applicant: Wallaby Medical: 22901 Mill Creek ...6 days ago · Date Received: 02/07/2022: Decision Date: 05/25/2022: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Cardiovascular 510 (k) Number. K222813. Device Name. Nitrile Examination Gloves. Applicant. Ecoglove Medical Manufacturing Company Limited. A Part of Land plot No. 679, map No. 41, N4 Street, Bau Bang Hamlet. Lai Uyen Town, Bau Bang District, VN.Date Received: 07/13/2023: Decision Date: 12/08/2023: Decision: Substantially Equivalent (SESE) Regulation Medical Specialty: Dental 510k Review Panel22. 510 (k) Number. K151372. Device Name. Low Dose CT Lung Cancer Screening Option for Qualified GE Systems. Applicant. GE Medical Systems, LLC. 3000 North Grandview Blvd. Waukesha, WI 53188.When you purchase a new appliance, it’s important to register it with the manufacturer. Registering your appliance not only ensures that you receive any safety or recall notificati...The FDA describes the Premarket Notification 510 (k) Database in the following way: "A 510 (K) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR §807.92 (a) (3)) that is not subject to premarket approval .... Bx42 bus map