FDA 510(k) Application Details - K974088

Device Classification Name	Device, Monitoring, Intracranial Pressure   More FDA Info for this Device
510(K) Number	K974088
Device Name	Device, Monitoring, Intracranial Pressure
Applicant	JOHNSON & JOHNSON PROFESSIONALS, INC. 325 PARAMOUNT DR. RAYNHAM, MA 02767 US Other 510(k) Applications for this Company
Contact	JAMES M FLAHERTY JR. 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	10/30/1997
Decision Date	01/09/1998
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