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FDA 510(k) Application Details - K201989
Device Classification Name
Device, Monitoring, Intracranial Pressure
More FDA Info for this Device
510(K) Number
K201989
Device Name
Device, Monitoring, Intracranial Pressure
Applicant
Braincare Desenvolvimento e Inovacao Tecnologica S.A.
Avenida Bruno Ruggiero Filho, 971
Sao Carlos 13562-420 BR
Other 510(k) Applications for this Company
Contact
Arnaldo Betta
Other 510(k) Applications for this Contact
Regulation Number
882.1620
More FDA Info for this Regulation Number
Classification Product Code
GWM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/17/2020
Decision Date
10/08/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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