FDA 510(k) Application Details - K061907

Device Classification Name	Index-Generating Electroencephalograph Software   More FDA Info for this Device
510(K) Number	K061907
Device Name	Index-Generating Electroencephalograph Software
Applicant	GE HEALTHCARE 86 PILGRIM ROAD NEEDHAM, MA 02492 US Other 510(k) Applications for this Company
Contact	JOEL C KENT Other 510(k) Applications for this Contact
Regulation Number	882.1400   More FDA Info for this Regulation Number
Classification Product Code	OLW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/05/2006
Decision Date	03/27/2008
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