FDA 510(k)

B4C System

Número K: K201989 · 2021-10-08

RequerenteBraincare Desenvolvimento E Inovacao Tecnologica S.A.

Data da decisão2021-10-08

Código do produtoGWM

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

B4C System is the device name listed in this FDA 510(k) record. The listed applicant is Braincare Desenvolvimento E Inovacao Tecnologica S.A.. It received FDA 510(k) clearance on 2021-10-08 under 510(k) number K201989. The device is classified under product code GWM. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the B4C System?

B4C System is a medical device that received FDA 510(k) clearance on 2021-10-08. The listed applicant is Braincare Desenvolvimento E Inovacao Tecnologica S.A.. The 510(k) number is K201989.

When did B4C System receive FDA 510(k) clearance?

B4C System received FDA 510(k) clearance on 2021-10-08, under 510(k) number K201989.

Who is the listed applicant for B4C System?

The FDA 510(k) record lists Braincare Desenvolvimento E Inovacao Tecnologica S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for B4C System?

The FDA product code for B4C System is GWM.

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