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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 a medical device manufactured by Amd Medicom, Inc.. It received FDA 510(k) clearance on 2020-01-17 under approval 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. It is manufactured by Amd Medicom, Inc.. The 510(k) number is K190306.

When was AMD Ritmed AssureWear VersaGown approved by the FDA?

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

What company makes AMD Ritmed AssureWear VersaGown?

AMD Ritmed AssureWear VersaGown is manufactured by Amd Medicom, Inc..

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

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

Other Devices by Amd Medicom, Inc.

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)

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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.

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