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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 K974792
Device Name CS/3(TM) MONITORS*
Applicant
Datex-Engstrom, Inc.
2 Highwood Dr.
Tewksbury,  MA  01876
Applicant Contact JOEL KENT
Correspondent
Datex-Engstrom, Inc.
2 Highwood Dr.
Tewksbury,  MA  01876
Correspondent Contact JOEL KENT
Regulation Number870.1025
Classification Product Code
DSI  
Date Received12/22/1997
Decision Date 06/02/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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