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510(k) K240821

B4C System - Addition of new sensor model (BcSs-PICNIW-2000) by Braincare Desenvolvimento E Inovação Tecnológica S.A. — Product Code GWM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2024
Date Received
March 25, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Monitoring, Intracranial Pressure
Device Class
Class II
Regulation Number
882.1620
Review Panel
NE
Submission Type

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