FDA 510(k)

Medical mask (Model: KKF-1A)

Número K: K202316 · 2021-03-03

RequerenteHan Zhaoqing Sporting Goods Company Limited

Data da decisão2021-03-03

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Medical mask (Model: KKF-1A) is the device name listed in this FDA 510(k) record. The listed applicant is Han Zhaoqing Sporting Goods Company Limited. It received FDA 510(k) clearance on 2021-03-03 under 510(k) number K202316. 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 mask (Model: KKF-1A)?

Medical mask (Model: KKF-1A) is a medical device that received FDA 510(k) clearance on 2021-03-03. The listed applicant is Han Zhaoqing Sporting Goods Company Limited. The 510(k) number is K202316.

When did Medical mask (Model: KKF-1A) receive FDA 510(k) clearance?

Medical mask (Model: KKF-1A) received FDA 510(k) clearance on 2021-03-03, under 510(k) number K202316.

Who is the listed applicant for Medical mask (Model: KKF-1A)?

The FDA 510(k) record lists Han Zhaoqing Sporting Goods Company Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medical mask (Model: KKF-1A)?

The FDA product code for Medical mask (Model: KKF-1A) is FXX.

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Outros registros que listam Han Zhaoqing Sporting Goods Company Limited como candidato(a)

K202314Procedure face mask (Model: KKF-2A)

Dispositivos Relacionados (Código: FXX)

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Fonte oficial

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