FDA 510(k) Application Details - K980380

Device Classification Name	Device, Monitoring, Intracranial Pressure   More FDA Info for this Device
510(K) Number	K980380
Device Name	Device, Monitoring, Intracranial Pressure
Applicant	DIAMETRICS MEDICAL, LTD. SHORT STREET HIGH WYCOMBE, BUCKINGHAMSHIRE HP11 2QH GB Other 510(k) Applications for this Company
Contact	JAN WALTERS 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	02/02/1998
Decision Date	07/14/1999
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