FDA 510(k)

Medical Protective Mask

Número K: K202107 · 2021-01-15

RequerenteGuangdong Kingfa Sci. & Tech.Co., Ltd.

Data da decisão2021-01-15

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Medical Protective Mask is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Kingfa Sci. & Tech.Co., Ltd.. It received FDA 510(k) clearance on 2021-01-15 under 510(k) number K202107. 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 Protective Mask?

Medical Protective Mask is a medical device that received FDA 510(k) clearance on 2021-01-15. The listed applicant is Guangdong Kingfa Sci. & Tech.Co., Ltd.. The 510(k) number is K202107.

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

Medical Protective Mask received FDA 510(k) clearance on 2021-01-15, under 510(k) number K202107.

Who is the listed applicant for Medical Protective Mask?

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

What is the FDA product code for Medical Protective Mask?

The FDA product code for Medical Protective Mask is FXX.

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Fonte oficial

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