FDA 510(k) Application Details - K063797

Device Classification Name	Non-Normalizing Quantitative Electroencephalograph Software   More FDA Info for this Device
510(K) Number	K063797
Device Name	Non-Normalizing Quantitative Electroencephalograph Software
Applicant	ELECTRICAL GEODESICS, INCORPORATED 29611 SIMMONS ROAD EUGENE, OR 97405 US Other 510(k) Applications for this Company
Contact	LINDA J BOVARD Other 510(k) Applications for this Contact
Regulation Number	882.1400   More FDA Info for this Regulation Number
Classification Product Code	OLT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/22/2006
Decision Date	01/25/2007
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	N
Expedited Review