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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 K854175
Device Name DEFIGARD 2000
Applicant
Odam
19, Ave. De La Gare
B.P. 50
Wissembourg Cedex,  FR 67162
Applicant Contact CANSELL
Correspondent
Odam
19, Ave. De La Gare
B.P. 50
Wissembourg Cedex,  FR 67162
Correspondent Contact CANSELL
Regulation Number870.5300
Classification Product Code
LDD  
Date Received10/15/1985
Decision Date 01/13/1986
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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