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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 K972282
Device Name SPACELABS MEDICAL PCIS PATIENT MONITORS
Applicant
Spacelabs Medical, Inc.
P.O. Box 97013
Redmond,  WA  98073 -9713
Applicant Contact RUSS GARRSION
Correspondent
Spacelabs Medical, Inc.
P.O. Box 97013
Redmond,  WA  98073 -9713
Correspondent Contact RUSS GARRSION
Regulation Number870.1025
Classification Product Code
DSI  
Date Received06/18/1997
Decision Date 09/25/1997
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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