FDA 510(k) Application Details - K020285

Device Classification Name	Device, Monitoring, Intracranial Pressure   More FDA Info for this Device
510(K) Number	K020285
Device Name	Device, Monitoring, Intracranial Pressure
Applicant	CMA MICRODIALYSIS AB 49 PLAIN ST. NORTH ATTLEBORO, MA 02760 US Other 510(k) Applications for this Company
Contact	SHEILA HEMEON-HEYER 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	01/28/2002
Decision Date	10/23/2002
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