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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 K201989
Device Name B4C System
Applicant
Braincare Desenvolvimento E Inovacao Tecnologica S.A.
Avenida Bruno Ruggiero Filho, 971
São Carlos,  BR 13562-420
Applicant Contact Arnaldo Betta
Correspondent
Msquared Associates, Inc.
127 W. 30th St.,
9th Floor
New York,  NY  10001
Correspondent Contact Connie Qiu
Regulation Number882.1620
Classification Product Code
GWM  
Date Received07/17/2020
Decision Date 10/08/2021
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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