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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 K240821
Device Name B4C System - Addition of new sensor model (BcSs-PICNIW-2000)
Applicant
Braincare Desenvolvimento E Inovação Tecnológica S.A.
Avenida Bruno Ruggiero Filho, 971
São Carlos,  BR 13562-420
Applicant Contact Arnaldo Betta
Correspondent
ProPharma MedTech
1129 20th St. NW Suite 600
Washington,  DC  20036
Correspondent Contact Cherita James
Regulation Number882.1620
Classification Product Code
GWM  
Date Received03/25/2024
Decision Date 07/18/2024
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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