FDA 510(k)

Surgical Mask

N.º K: K212997 · 2022-01-14

SolicitanteGuangdong Zhizhen Biological Medical Co., Ltd.

Fecha de decisión2022-01-14

Código de productoFXX

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Zhizhen Biological Medical Co., Ltd.. It received FDA 510(k) clearance on 2022-01-14 under 510(k) number K212997. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Surgical Mask?

Surgical Mask is a medical device that received FDA 510(k) clearance on 2022-01-14. The listed applicant is Guangdong Zhizhen Biological Medical Co., Ltd.. The 510(k) number is K212997.

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

Surgical Mask received FDA 510(k) clearance on 2022-01-14, under 510(k) number K212997.

Who is the listed applicant for Surgical Mask?

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

What is the FDA product code for Surgical Mask?

The FDA product code for Surgical Mask is FXX.

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Dispositivos relacionados (Código: FXX)

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Fuente oficial

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