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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 K882472
Device Name LOGIC 3 ELECTROCARDIOGRAPH
Original Applicant
CEL-MED CO., INC.
625 franklin turnpike
ridgewood,  NJ  07450
Original Contact vincent celentano
Regulation Number870.2340
Classification Product Code
DPS  
Date Received06/15/1988
Decision Date 11/17/1988
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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