FDA 510(k)

Medical Face Mask (M001)

Número K: K221273 · 2022-06-28

Data da decisão2022-06-28

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Medical Face Mask (M001) is the device name listed in this FDA 510(k) record. The listed applicant is Xingyu Medical Tech Co., Ltd.. It received FDA 510(k) clearance on 2022-06-28 under 510(k) number K221273. 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 Face Mask (M001)?

Medical Face Mask (M001) is a medical device that received FDA 510(k) clearance on 2022-06-28. The listed applicant is Xingyu Medical Tech Co., Ltd.. The 510(k) number is K221273.

When did Medical Face Mask (M001) receive FDA 510(k) clearance?

Medical Face Mask (M001) received FDA 510(k) clearance on 2022-06-28, under 510(k) number K221273.

Who is the listed applicant for Medical Face Mask (M001)?

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

What is the FDA product code for Medical Face Mask (M001)?

The FDA product code for Medical Face Mask (M001) is FXX.

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