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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vectorcardiograph
510(k) Number K823934
Device Name CARIEL F12
Applicant
Odam
Siege Social
67160 Wissembourg
France,  FR
Applicant Contact REITHLER
Correspondent
Odam
Siege Social
67160 Wissembourg
France,  FR
Correspondent Contact REITHLER
Regulation Number870.2400
Classification Product Code
DYC  
Date Received12/29/1982
Decision Date 12/16/1983
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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