FDA 510(k) Application Details - K102077

Device Classification Name	Device, Monitoring, Intracranial Pressure   More FDA Info for this Device
510(K) Number	K102077
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	07/23/2010
Decision Date	01/14/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review