FDA 510(k)

Comfort Gown, Safewear Gown

Número K: K213893 · 2022-12-21

RequerenteXuchang Zhengde Environstar Medical Products Co., Ltd.

Data da decisão2022-12-21

Código do produtoFYA

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Comfort Gown, Safewear Gown is the device name listed in this FDA 510(k) record. The listed applicant is Xuchang Zhengde Environstar Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2022-12-21 under 510(k) number K213893. 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 Comfort Gown, Safewear Gown?

Comfort Gown, Safewear Gown is a medical device that received FDA 510(k) clearance on 2022-12-21. The listed applicant is Xuchang Zhengde Environstar Medical Products Co., Ltd.. The 510(k) number is K213893.

When did Comfort Gown, Safewear Gown receive FDA 510(k) clearance?

Comfort Gown, Safewear Gown received FDA 510(k) clearance on 2022-12-21, under 510(k) number K213893.

Who is the listed applicant for Comfort Gown, Safewear Gown?

The FDA 510(k) record lists Xuchang Zhengde Environstar Medical Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Comfort Gown, Safewear Gown?

The FDA product code for Comfort Gown, Safewear Gown is FYA.

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Outros registros que listam Xuchang Zhengde Environstar Medical Products Co., Ltd. como candidato(a)

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Dispositivos Relacionados (Código: FYA)

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Fonte oficial

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