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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Magnetic Tape, Medical
510(k) Number K853262
Device Name CARDIO DATA PACERECORDER PR3
Applicant
Cardio Data
71 Lyman St.
Northborough,  MA  01532
Applicant Contact BETTY LANE
Correspondent
Cardio Data
71 Lyman St.
Northborough,  MA  01532
Correspondent Contact BETTY LANE
Regulation Number870.2800
Classification Product Code
DSH  
Date Received08/05/1985
Decision Date 10/11/1985
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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