FDA 510(k)

Disposable Surgical Gown

Número K: K212591 · 2022-01-11

RequerenteSuzhou Janee Medical Technology Co., Ltd.

Data da decisão2022-01-11

Código do produtoFYA

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Disposable Surgical Gown is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Janee Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-01-11 under 510(k) number K212591. The device is classified under product code FYA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Disposable Surgical Gown?

Disposable Surgical Gown is a medical device that received FDA 510(k) clearance on 2022-01-11. The listed applicant is Suzhou Janee Medical Technology Co., Ltd.. The 510(k) number is K212591.

When did Disposable Surgical Gown receive FDA 510(k) clearance?

Disposable Surgical Gown received FDA 510(k) clearance on 2022-01-11, under 510(k) number K212591.

Who is the listed applicant for Disposable Surgical Gown?

The FDA 510(k) record lists Suzhou Janee Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Surgical Gown?

The FDA product code for Disposable Surgical Gown is FYA.

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Fonte oficial

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