FDA 510(k)

Medical Face Mask

N.º K: K212471 · 2021-11-04

Fecha de decisión2021-11-04

Código de productoFXX

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Medical Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Haian Medigauze Co., Ltd.. It received FDA 510(k) clearance on 2021-11-04 under 510(k) number K212471. 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 Medical Face Mask?

Medical Face Mask is a medical device that received FDA 510(k) clearance on 2021-11-04. The listed applicant is Haian Medigauze Co., Ltd.. The 510(k) number is K212471.

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

Medical Face Mask received FDA 510(k) clearance on 2021-11-04, under 510(k) number K212471.

Who is the listed applicant for Medical Face Mask?

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

What is the FDA product code for Medical Face Mask?

The FDA product code for Medical Face Mask is FXX.

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Fuente oficial

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