FDA 510(k)

Disposable Medical Surgical Mask

Número K: K212375 · 2022-01-04

RequerenteJiangxi Bestgrand Health Technology Co., Ltd.

Data da decisão2022-01-04

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Disposable Medical Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Jiangxi Bestgrand Health Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-01-04 under 510(k) number K212375. 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 Disposable Medical Surgical Mask?

Disposable Medical Surgical Mask is a medical device that received FDA 510(k) clearance on 2022-01-04. The listed applicant is Jiangxi Bestgrand Health Technology Co., Ltd.. The 510(k) number is K212375.

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

Disposable Medical Surgical Mask received FDA 510(k) clearance on 2022-01-04, under 510(k) number K212375.

Who is the listed applicant for Disposable Medical Surgical Mask?

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

What is the FDA product code for Disposable Medical Surgical Mask?

The FDA product code for Disposable Medical Surgical Mask is FXX.

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