FDA 510(k) Application Details - K052981

Device Classification Name	Index-Generating Electroencephalograph Software   More FDA Info for this Device
510(K) Number	K052981
Device Name	Index-Generating Electroencephalograph Software
Applicant	ASPECT MEDICAL SYSTEMS, INC. 141 NEEDHAM ST. NEWTON, MA 02464 US Other 510(k) Applications for this Company
Contact	CHRISTINE VOZELLA 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	10/24/2005
Decision Date	11/01/2005
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