FDA 510(k)

Copioumed Chemotherapy Isolation Gown

K-Number: K230135 · 2023-10-04

Decision Date2023-10-04

Product CodeFYC

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Copioumed Chemotherapy Isolation Gown is a medical device manufactured by Copioumed International, Inc.. It received FDA 510(k) clearance on 2023-10-04 under approval number K230135. 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 Copioumed Chemotherapy Isolation Gown?

Copioumed Chemotherapy Isolation Gown is a medical device that received FDA 510(k) clearance on 2023-10-04. It is manufactured by Copioumed International, Inc.. The 510(k) number is K230135.

When was Copioumed Chemotherapy Isolation Gown approved by the FDA?

Copioumed Chemotherapy Isolation Gown received FDA 510(k) clearance on 2023-10-04, under approval number K230135.

What company makes Copioumed Chemotherapy Isolation Gown?

Copioumed Chemotherapy Isolation Gown is manufactured by Copioumed International, Inc..

What is the FDA product code for Copioumed Chemotherapy Isolation Gown?

The FDA product code for Copioumed Chemotherapy Isolation Gown is FYC.

Other Devices by Copioumed International, Inc.

K251860Copioumed AAMI 3 Surgical Gown

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Official Source

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