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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Detector And Alarm, Arrhythmia
510(k) Number K972502
Device Name SPACELABS MEDICAL INTEGRATED MULTIPARAMETER MODULE 90496
Applicant
Spacelabs Medical, Inc.
P.O. Box 97013
Redmond,  WA  98073
Applicant Contact RUSS GARRISON
Correspondent
Spacelabs Medical, Inc.
P.O. Box 97013
Redmond,  WA  98073
Correspondent Contact RUSS GARRISON
Regulation Number870.1025
Classification Product Code
DSI  
Date Received07/03/1997
Decision Date 05/28/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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