FDA 510(k) Application Details - K010965

Device Classification Name	Index-Generating Electroencephalograph Software   More FDA Info for this Device
510(K) Number	K010965
Device Name	Index-Generating Electroencephalograph Software
Applicant	ALARIS MEDICAL SYSTEMS, INC. 10221 WATERIDGE CIR. SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	RENEE FLUET 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	04/02/2001
Decision Date	06/27/2001
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