Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AMD Ritmed AssureWear VersaGown

K-Number: K190306 · 2020-01-17

ApplicantAmd Medicom, Inc.
Decision Date2020-01-17
Product CodeFYC
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AMD Ritmed AssureWear VersaGown is the device name listed in this FDA 510(k) record. The listed applicant is Amd Medicom, Inc.. It received FDA 510(k) clearance on 2020-01-17 under 510(k) number K190306. The device is classified under product code FYC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMD Ritmed AssureWear VersaGown?

AMD Ritmed AssureWear VersaGown is a medical device that received FDA 510(k) clearance on 2020-01-17. The listed applicant is Amd Medicom, Inc.. The 510(k) number is K190306.

When did AMD Ritmed AssureWear VersaGown receive FDA 510(k) clearance?

AMD Ritmed AssureWear VersaGown received FDA 510(k) clearance on 2020-01-17, under 510(k) number K190306.

Who is the listed applicant for AMD Ritmed AssureWear VersaGown?

The FDA 510(k) record lists Amd Medicom, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMD Ritmed AssureWear VersaGown?

The FDA product code for AMD Ritmed AssureWear VersaGown is FYC.

Other records listing Amd Medicom, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K190308Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks, Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1)

Related Devices (Code: FYC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232849Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311)Owens & Minor (O&M) Halyard, Inc.K230135Copioumed Chemotherapy Isolation GownCopioumed International, Inc.K223467Disposable Isolation GownNanning Tecbod Biological Technology Co., Ltd.K223304Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)Xiamen Probtain Medical Technology Co., Ltd.K223411Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL)Xiamen Probtain Medical Techology Co., Ltd.K212717Paneffort AAMI Level 3 Isolation GownPaneffort, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑