FDA 510(k) Application Details - K162108

Device Classification Name	Device, Monitoring, Intracranial Pressure   More FDA Info for this Device
510(K) Number	K162108
Device Name	Device, Monitoring, Intracranial Pressure
Applicant	SOPHYSA, SA 5, rue Guy Moquet ORSAY, Cedex 91400 FR Other 510(k) Applications for this Company
Contact	Jean-Christophe Audras 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	07/29/2016
Decision Date	04/17/2017
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