Cdrh 510 k database search

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August undefined, 2024

Web510(K) Summary-K220673 1/5 510(K) Summary - K220673 This 510(K) Summary information is being submitted in accordance with 21 CFR 807.92. I. SUBMITTER: …

510(k) Premarket Notification - Food and Drug Administration

WebJul 27, 2009 · FDA > CDRH > CFR Title 21 Database Search Sec. 886.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). … WebThe Center for Devices and Radiological Health (CDRH) is the component within the FDA that is responsible for this program. The FDA's legal authority to regulate both medical … go to the other tower dying light 2

Device Approvals, Denials and Clearances FDA

WebFDA Home Page CDRH Home Page Search CDRH A-Z Index Contact CDRH 510(k) Registration Listing Adverse Events PMA Classification CLIA CFR Title 21 … Web510(k)s; De Novo; Medical Device Reports (MAUDE) CDRH Export Certificate Validation (CECV) CDRH FOIA Electronic Reading Room; CFR Title 21; CLIA; Device … Web510(K) Summary-K220673 1/5 510(K) Summary - K220673 This 510(K) Summary information is being submitted in accordance with 21 CFR 807.92. I. SUBMITTER: Qingdao Bright Moon Biomedical Materials Co., Ltd. No. 788, Bright Moon Road, Huangdao District, Qingdao, Shandong,China Contact Person: Deng yunlong go to the park for a picnic

BioFire Defense, LLC March 22, 2024 David Rabiger Associate …

Product Code Classification Database FDA

Web510(K) Number. Decision Date. single size tendon spacer: MEDIST INTERNATIONAL k000019: 03/29/2000: cortek mini laparoscope: CORTEK ENDOSCOPY, INC. k000199: … WebJan 5, 2024 · This page lists all medical devices cleared through the CDRH Premarket Notification process [510(K)] in 2024. January 2024 510(K) Clearances; February 2024 … go to the park cartoonWebDatabases. A 510 (K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a … child friendly family tree template

"WebGalaxy System 510(k) Notification Page 1 of 4 510(k) Summary This summary of 510(k) for information regarding substantial equivalency is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. 510(k) Number: K223144 Applicant Information: Date Prepared: Manufacturer: Contact Person: Mobile Number: Fax: Device ... " - Cdrh 510 k database search

Cdrh 510 k database search

WebMar 20, 2024 · While the CDRH Portal features online progress tracking for 510 (k) submissions, the FDA also formally notifies you of your 510 (k) submission's status by … Web510(k)s; Medical Device Reports (MAUDE) CDRH Export Certificate Validation (CECV) CDRH FOIA Electronic Reading Room; CFR Title 21; CLIA; Device Classification; FDA …

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Web510(k) Summary K223609 RevCore™ Thrombectomy Catheter The following “510(k) Summary” of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92. 1.0 Submitter Information [ 21 CFR 807.92(a) (1)] Submitter: Inari Medical, Inc. Address: 6001 Oak Canyon, Suite 100 Irvine, CA 92618 USA WebThese sets were previously cleared under 510(k) premarket notification K932512 on Feb 22, 1994. The devices covered in this submission are substantially equivalent to the …

WebCDRH maintains searchable databases on its website containing 510(k) and PMA information. A 510(k) is a premarketing submission made to FDA to demonstrate that the … WebThese sets were previously cleared under 510(k) premarket notification K932512 on Feb 22, 1994. The devices covered in this submission are substantially equivalent to the predicate devices, previously cleared under 510(k) premarket notification K130245 on March 1, 2013. The intended use and function of the proposed devices are equivalent to

WebMay 2, 2024 · In accordance with that principle, since 510(k) applications are the most frequently requested CDRH records, CDRH is posting 510(k) records released to the … Web510(k)s; De Novo; Medical Device Reports (MAUDE) CDRH Export Certificate Validation (CECV) CDRH FOIA Electronic Reading Room; CFR Title 21; CLIA; Device …

WebBioFire® Global Fever Special Pathogens Panel 510(k) Summary BioFire Defense, LLC IV. Device Description The BioFire® Global Fever Special Pathogens Panel is a multiplexed nucleic acid-based test designed to be used with BioFire ®®FilmArray Systems (BioFire FilmArray® 2.0 or BioFire® FilmArray® Torch). The BioFire Global Fever Special …

WebFemDx Medsystems, Inc. Traditional 510(k) FemDx FalloViewTM Page 1 of 5 510(k) Summary Date Prepared: March 15, 2024 Submitter: FemDx Medsystems, Inc. 2336 Walsh Avenue, Suite A . Santa Clara, CA 95051 . Contact Person: Xi Francis, CEO . Email: [email protected] . Trade/Device Name: FemDx FalloView TM. Common … child friendly free online dictionaryWeb510(k) Premarket Notification (Traditional) for ECHELON LINEARTM Cutter 510(k) Summary I. SUBMITTER Company: Ethicon Endo-Surgery, LLC 475 Calle C Guaynabo, PR 00969 Contact: Alicia Butler Senior Regulatory Affairs Specialist Ethicon Endo-Surgery, Inc. Phone: 513-337-1633 Email: [email protected] Date Prepared: December 15, 2024 II. child friendly formulationWeb510(k) Premarket Notification (Traditional) for ECHELON LINEARTM Cutter 510(k) Summary I. SUBMITTER Company: Ethicon Endo-Surgery, LLC 475 Calle C Guaynabo, … go to the park in spanishWebA search query will produce information from the database in the following format: You can search the releasable 510(k) database by Panel, 510(k) number, Product code or … A 510(K) is a premarket submission made to FDA to demonstrate that the device to … Listings of CDRH Substantially Equivalent 510(k)s are normally available about the … go to the park是什么意思WebFDA > CDRH > Device Registra Database Search. words connected by and (e.g., electromechanical and infusion). To Search by Establishment, Registration Number or … child friendly festivals 2023Web28 rows · Apr 6, 2024 · CDRH Databases: a listing of databases for such topics as … child friendly garden ideasWebThe Product Classification Database contains medical device names and associated information developed by the Center for Devices and Radiological Health (CDRH) in … go to the other song