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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Monitoring, Intracranial Pressure
510(k) Number K182073
Device Name BcSs-PICNI-2000 Sensor
Applicant
Braincare desenvolvimento e Inovacao Tecnologica S.A.
Rua Cid Silva Cesar, 600 sala 6,
Parque Jardim Santa Felicia
Sao Carlos,  BR 13562-400
Applicant Contact Arnaldo Betta
Correspondent
M Squared Associates, Inc.
575 8th Ave, Suite 1212
New York,  NY  10018
Correspondent Contact Connie Qiu
Regulation Number882.1620
Classification Product Code
GWM  
Date Received08/01/2018
Decision Date 10/17/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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