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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
Applicant
Cel-Med Co., Inc.
625 Franklin Tpke.
Ridgewood,  NJ  07450
Applicant Contact VINCENT CELENTANO
Correspondent
Cel-Med Co., Inc.
625 Franklin Tpke.
Ridgewood,  NJ  07450
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
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