FDA 510(k) Application Details - K152670

Device Classification Name	Device, Monitoring, Intracranial Pressure   More FDA Info for this Device
510(K) Number	K152670
Device Name	Device, Monitoring, Intracranial Pressure
Applicant	Medos International SARL Chemin-Blanc 38 Le Locle CH-2400 CH Other 510(k) Applications for this Company
Contact	Elena Jugo 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	09/17/2015
Decision Date	01/22/2016
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