FDA 510(k)

Disposable Surgical Mask

Número K: K212944 · 2021-12-15

RequerenteHeilongjiang Yinjia Medical Equipment Co., Ltd.

Data da decisão2021-12-15

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Disposable Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Heilongjiang Yinjia Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2021-12-15 under 510(k) number K212944. 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 Disposable Surgical Mask?

Disposable Surgical Mask is a medical device that received FDA 510(k) clearance on 2021-12-15. The listed applicant is Heilongjiang Yinjia Medical Equipment Co., Ltd.. The 510(k) number is K212944.

When did Disposable Surgical Mask receive FDA 510(k) clearance?

Disposable Surgical Mask received FDA 510(k) clearance on 2021-12-15, under 510(k) number K212944.

Who is the listed applicant for Disposable Surgical Mask?

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

What is the FDA product code for Disposable Surgical Mask?

The FDA product code for Disposable Surgical Mask is FXX.

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