BcSs-PICNI-2000 Sensor

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 Bcss-picni-2000 Sensor.

Pre-market Notification Details

Device IDK182073
510k NumberK182073
Device Name:BcSs-PICNI-2000 Sensor
ClassificationDevice, Monitoring, Intracranial Pressure
Applicant Braincare Desenvolvimento E Inovacao Tecnologica S.A. Rua Cid Silva Cesar, 600 Sala 6, Parque Jardim Santa Felicia Sao Carlos,  BR 13562-400
ContactArnaldo Betta
CorrespondentConnie Qiu
M Squared Associates, Inc. 575 8th Ave, Suite 1212 New York,  NY  10018
Product CodeGWM  
CFR Regulation Number882.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-08-01
Decision Date2019-10-17

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