FDA 510(k)

Medical surgical mask

Número K: K202842 · 2021-11-26

Data da decisão2021-11-26

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Medical surgical mask is the device name listed in this FDA 510(k) record. The listed applicant is Henan Huibo Medical Co., Ltd.. It received FDA 510(k) clearance on 2021-11-26 under 510(k) number K202842. 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 surgical mask?

Medical surgical mask is a medical device that received FDA 510(k) clearance on 2021-11-26. The listed applicant is Henan Huibo Medical Co., Ltd.. The 510(k) number is K202842.

When did Medical surgical mask receive FDA 510(k) clearance?

Medical surgical mask received FDA 510(k) clearance on 2021-11-26, under 510(k) number K202842.

Who is the listed applicant for Medical surgical mask?

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

What is the FDA product code for Medical surgical mask?

The FDA product code for Medical surgical mask is FXX.

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