FDA 510(k) Application Details - K973596

Device Classification Name	Index-Generating Electroencephalograph Software   More FDA Info for this Device
510(K) Number	K973596
Device Name	Index-Generating Electroencephalograph Software
Applicant	SPACELABS MEDICAL, INC. 15220 NORTH EAST 40TH ST. P.O. BOX 97013 REDMOND, WA 98052 US Other 510(k) Applications for this Company
Contact	RUSS GARRISON 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	09/22/1997
Decision Date	02/03/1998
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