
Defibtech, LLC
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DEFIBTECH AED WITH ATTENUATED DEFIBRILLATION/MONITORING PADS, MODELS DDU-100 WITH DDP-200P is an FDA 510(k)-cleared medical device (K033896) 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 15, 2004. Regulation: 8.