FDA 510(k)

CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown

Número K: K210414 · 2022-10-21

Data da decisão2022-10-21

Código do produtoFYC

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown is the device name listed in this FDA 510(k) record. The listed applicant is Medtecs (Taiwan) Corp.. It received FDA 510(k) clearance on 2022-10-21 under 510(k) number K210414. The device is classified under product code FYC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown?

CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown is a medical device that received FDA 510(k) clearance on 2022-10-21. The listed applicant is Medtecs (Taiwan) Corp.. The 510(k) number is K210414.

When did CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown receive FDA 510(k) clearance?

CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown received FDA 510(k) clearance on 2022-10-21, under 510(k) number K210414.

Who is the listed applicant for CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown?

The FDA 510(k) record lists Medtecs (Taiwan) Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown?

The FDA product code for CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown is FYC.

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Fonte oficial

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