FDA 510(k) Application Details - K962930

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K962930
Device Name	Computer, Diagnostic, Programmable
Applicant	SPACELABS MEDICAL, INC. P.O. BOX 97013 REDMOND, WA 98073-9713 US Other 510(k) Applications for this Company
Contact	RUSS GARRISON Other 510(k) Applications for this Contact
Regulation Number	870.1425   More FDA Info for this Regulation Number
Classification Product Code	DQK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/29/1996
Decision Date	04/25/1997
Decision	SEKD - SUBST EQUIV - KIT WITH DRUGS
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review