FDA 510(k)

BASE4 Disposable Medical Mask

Número K: K202069 · 2020-12-01

Data da decisão2020-12-01

Código do produtoFXX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

BASE4 Disposable Medical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Base4 Group, Inc.. It received FDA 510(k) clearance on 2020-12-01 under 510(k) number K202069. 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 BASE4 Disposable Medical Mask?

BASE4 Disposable Medical Mask is a medical device that received FDA 510(k) clearance on 2020-12-01. The listed applicant is Base4 Group, Inc.. The 510(k) number is K202069.

When did BASE4 Disposable Medical Mask receive FDA 510(k) clearance?

BASE4 Disposable Medical Mask received FDA 510(k) clearance on 2020-12-01, under 510(k) number K202069.

Who is the listed applicant for BASE4 Disposable Medical Mask?

The FDA 510(k) record lists Base4 Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BASE4 Disposable Medical Mask?

The FDA product code for BASE4 Disposable Medical Mask is FXX.

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