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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
Msquared 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
Predetermined Change
Control Plan Authorized		 No
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