FDA 510(k) Application Details - K013389

Device Classification Name	Index-Generating Electroencephalograph Software   More FDA Info for this Device
510(K) Number	K013389
Device Name	Index-Generating Electroencephalograph Software
Applicant	DATEX-OHMEDA 86 PILGRIM RD. NEEDHAM, MA 02492 US Other 510(k) Applications for this Company
Contact	JOEL 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	10/12/2001
Decision Date	01/10/2002
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