FDA 510(k) Application Details - K013705

Device Classification Name	Device, Monitoring, Intracranial Pressure   More FDA Info for this Device
510(K) Number	K013705
Device Name	Device, Monitoring, Intracranial Pressure
Applicant	INNERSPACE, INC. 2933 SOUTH PULLMAN ST., SUITE A SANTA ANA, CA 92705 US Other 510(k) Applications for this Company
Contact	DONALD E BOBO 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	11/08/2001
Decision Date	09/09/2002
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