FDA 510(k) Application Details - K182073

Device Classification Name	Device, Monitoring, Intracranial Pressure   More FDA Info for this Device
510(K) Number	K182073
Device Name	Device, Monitoring, Intracranial Pressure
Applicant	Braincare desenvolvimento e Inovacao Tecnologica S.A. Rua Cid Silva Cesar, 600 sala 6, Parque Jardim Santa Felicia Sao Carlos 13562-400 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	08/01/2018
Decision Date	10/17/2019
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