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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrocardiograph
510(k) Number K811949
Device Name KENL-ECG-3
Original Applicant
SUZUKEN CO., LTD.
Regulation Number870.2340
Classification Product Code
DPS  
Date Received07/07/1981
Decision Date 08/13/1981
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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