FDA 510(k) Application Details - K071984

Device Classification Name	Device, Monitoring, Intracranial Pressure   More FDA Info for this Device
510(K) Number	K071984
Device Name	Device, Monitoring, Intracranial Pressure
Applicant	CMA MICRODIALYSIS AB 73 PRINCETON STREET NORTH CHELMSFORD, MA 01863 US Other 510(k) Applications for this Company
Contact	NANCY BLANCO 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	07/19/2007
Decision Date	06/27/2008
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