
Defibtech, LLC
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DDU-2300 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES is an FDA 510(k)-cleared medical device (K081259) 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 June 14, 2009. Regulation: 8.

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