FDA 510(k)

Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80)

Número K: K222266 · 2022-09-26

RequerenteJingzhou Haixin Green Cross Medical Products Co., Ltd.

Data da decisão2022-09-26

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80) is the device name listed in this FDA 510(k) record. The listed applicant is Jingzhou Haixin Green Cross Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2022-09-26 under 510(k) number K222266. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80)?

Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80) is a medical device that received FDA 510(k) clearance on 2022-09-26. The listed applicant is Jingzhou Haixin Green Cross Medical Products Co., Ltd.. The 510(k) number is K222266.

When did Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80) receive FDA 510(k) clearance?

Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80) received FDA 510(k) clearance on 2022-09-26, under 510(k) number K222266.

Who is the listed applicant for Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80)?

The FDA 510(k) record lists Jingzhou Haixin Green Cross Medical Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80)?

The FDA product code for Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80) is FXX.

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Fonte oficial

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