FDA 510(k)

Medical Surgical Mask

Número K: K212299 · 2022-01-04

RequerenteWepon Medical Technology Co., Ltd.

Data da decisão2022-01-04

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Medical Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Wepon Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-01-04 under 510(k) number K212299. 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 Medical Surgical Mask?

Medical Surgical Mask is a medical device that received FDA 510(k) clearance on 2022-01-04. The listed applicant is Wepon Medical Technology Co., Ltd.. The 510(k) number is K212299.

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

Medical Surgical Mask received FDA 510(k) clearance on 2022-01-04, under 510(k) number K212299.

Who is the listed applicant for Medical Surgical Mask?

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

What is the FDA product code for Medical Surgical Mask?

The FDA product code for Medical Surgical Mask is FXX.

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Fonte oficial

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