FDA 510(k) Application Details - K240821

Device Classification Name	Device, Monitoring, Intracranial Pressure   More FDA Info for this Device
510(K) Number	K240821
Device Name	Device, Monitoring, Intracranial Pressure
Applicant	Braincare Desenvolvimento e Inovaτπo Tecnol≤gica S.A. Avenida Bruno Ruggiero Filho, 971 Sπo 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	03/25/2024
Decision Date	07/18/2024
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