B4C System

Device, Monitoring, Intracranial Pressure

Braincare Desenvolvimento E Inovacao Tecnologica S.A.

The following data is part of a premarket notification filed by Braincare Desenvolvimento E Inovacao Tecnologica S.a. with the FDA for B4c System.

Pre-market Notification Details

Device IDK201989
510k NumberK201989
Device Name:B4C System
ClassificationDevice, Monitoring, Intracranial Pressure
Applicant Braincare Desenvolvimento E Inovacao Tecnologica S.A. Avenida Bruno Ruggiero Filho, 971 Sao Carlos,  BR 13562-420
ContactArnaldo Betta
CorrespondentConnie Qiu
M Squared Associates,Inc. 127 West 30th Street, 9th Floor New York,  NY  10001
Product CodeGWM  
CFR Regulation Number882.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-17
Decision Date2021-10-08

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