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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dc-Defibrillator, Low-Energy, (Including Paddles)
510(k) Number K823933
Device Name MINIDEF (OR DEFIPORT
Applicant
Odam
Siege Social
67160 Wissembourg
France,  FR
Correspondent
Odam
Siege Social
67160 Wissembourg
France,  FR
Regulation Number870.5300
Classification Product Code
LDD  
Date Received12/29/1982
Decision Date 04/12/1983
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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