FDA 510(k) Application Details - K001069

Device Classification Name	Index-Generating Electroencephalograph Software   More FDA Info for this Device
510(K) Number	K001069
Device Name	Index-Generating Electroencephalograph Software
Applicant	PHYSIOMETRIX, INC. FIVE BILLERICA PARK, 101 BILLERICA AVE. NORTH BILLERICA, MA 01862 US Other 510(k) Applications for this Company
Contact	DAWN E FRAZER 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	04/03/2000
Decision Date	06/30/2000
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