FDA 510(k) Application Details - K062613

Device Classification Name	Index-Generating Electroencephalograph Software   More FDA Info for this Device
510(K) Number	K062613
Device Name	Index-Generating Electroencephalograph Software
Applicant	ASPECT MEDICAL SYSTEMS, INC. ONE UPLAND ROAD NORWOOD, MA 02062 US Other 510(k) Applications for this Company
Contact	VIKRAM VERMA 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	09/05/2006
Decision Date	06/18/2007
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