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Defibtech, LLC
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DDU-2400/2450 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES is an FDA 510(k)-cleared medical device (K121853) manufactured by Defibtech, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on December 12, 2012. Regulation: 8.