FDA 510(k)

Yadu Medical Face Mask (Level 1)

Número K: K212330 · 2022-03-14

RequerenteHenan Yadu Industrial Co., Ltd.

Data da decisão2022-03-14

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Yadu Medical Face Mask (Level 1) is the device name listed in this FDA 510(k) record. The listed applicant is Henan Yadu Industrial Co., Ltd.. It received FDA 510(k) clearance on 2022-03-14 under 510(k) number K212330. 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 Yadu Medical Face Mask (Level 1)?

Yadu Medical Face Mask (Level 1) is a medical device that received FDA 510(k) clearance on 2022-03-14. The listed applicant is Henan Yadu Industrial Co., Ltd.. The 510(k) number is K212330.

When did Yadu Medical Face Mask (Level 1) receive FDA 510(k) clearance?

Yadu Medical Face Mask (Level 1) received FDA 510(k) clearance on 2022-03-14, under 510(k) number K212330.

Who is the listed applicant for Yadu Medical Face Mask (Level 1)?

The FDA 510(k) record lists Henan Yadu Industrial Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Yadu Medical Face Mask (Level 1)?

The FDA product code for Yadu Medical Face Mask (Level 1) is FXX.

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Outros registros que listam Henan Yadu Industrial Co., Ltd. como candidato(a)

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Fonte oficial

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