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510(k) K182073

BcSs-PICNI-2000 Sensor by Braincare Desenvolvimento E Inovacao Tecnologica S.A. — Product Code GWM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2019
Date Received
August 1, 2018
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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