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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 K925510
Device Name MODEL 90478 & 90479 TELEMETRY REC. MODULE&HOUSING
Applicant
Spacelabs Medical, Inc.
925 Sherman Ave.
Hamden,  CT  06514
Applicant Contact RAYMOND W GIFFORD
Correspondent
Spacelabs Medical, Inc.
925 Sherman Ave.
Hamden,  CT  06514
Correspondent Contact RAYMOND W GIFFORD
Regulation Number870.1025
Classification Product Code
DSI  
Date Received10/30/1992
Decision Date 10/27/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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