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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 Street 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
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