FDA 510(k)

Single-use medical face mask

Número K: K210391 · 2021-07-22

RequerenteZhuhai Herald Datanetics Limited.

Data da decisão2021-07-22

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Single-use medical face mask is the device name listed in this FDA 510(k) record. The listed applicant is Zhuhai Herald Datanetics Limited.. It received FDA 510(k) clearance on 2021-07-22 under 510(k) number K210391. 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 Single-use medical face mask?

Single-use medical face mask is a medical device that received FDA 510(k) clearance on 2021-07-22. The listed applicant is Zhuhai Herald Datanetics Limited.. The 510(k) number is K210391.

When did Single-use medical face mask receive FDA 510(k) clearance?

Single-use medical face mask received FDA 510(k) clearance on 2021-07-22, under 510(k) number K210391.

Who is the listed applicant for Single-use medical face mask?

The FDA 510(k) record lists Zhuhai Herald Datanetics Limited. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single-use medical face mask?

The FDA product code for Single-use medical face mask is FXX.

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