FDA 510(k) Application Details - K081151

Device Classification Name	Electroencephalograph   More FDA Info for this Device
510(K) Number	K081151
Device Name	Electroencephalograph
Applicant	COMPUMEDICS USA, LTD. 6605 WEST WT HARRIS BLVD SUITE F CHARLOTTE, NC 28269 US Other 510(k) Applications for this Company
Contact	DAVID CARDONA Other 510(k) Applications for this Contact
Regulation Number	882.1400   More FDA Info for this Regulation Number
Classification Product Code	GWQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/23/2008
Decision Date	09/08/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	Y
Expedited Review