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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 K881488
Device Name HOLTER SCANNER
Applicant
Cardiodata Corp.
71 Lyman St.
Northborough,  MA  01532
Applicant Contact BETTY LANE
Correspondent
Cardiodata Corp.
71 Lyman St.
Northborough,  MA  01532
Correspondent Contact BETTY LANE
Regulation Number870.1025
Classification Product Code
DSI  
Date Received04/08/1988
Decision Date 09/20/1988
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
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