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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 K900607
Device Name MK5 DETECTOR & ALARM, ARRHYTHMIA W/SOFTWARE 2.11
Applicant
Cardiodata Corp.
71 Lyman St.
Northborough,  MA  01532
Applicant Contact RODNEY L CAMBRE
Correspondent
Cardiodata Corp.
71 Lyman St.
Northborough,  MA  01532
Correspondent Contact RODNEY L CAMBRE
Regulation Number870.1025
Classification Product Code
DSI  
Date Received02/08/1990
Decision Date 10/16/1990
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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