FDA 510(k) Application Details - K003038

Device Classification Name	Index-Generating Electroencephalograph Software   More FDA Info for this Device
510(K) Number	K003038
Device Name	Index-Generating Electroencephalograph Software
Applicant	AGILENT TECHNOLOGIES DEUTSCHLAND GMBH HERRENBERGER ST. 130 BOEBLINGEN BOEBLINGEN, 71034 DE Other 510(k) Applications for this Company
Contact	EGON PFEIL 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	09/29/2000
Decision Date	12/15/2000
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