
Defibtech, LLC
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SENTRY SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR; EXTERNAL DEFIBRILLATION PADS (ELECTRODES) DDP-100; BATTERY PACK 1200MAH; BA is an FDA 510(k)-cleared medical device (K013896) 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 18, 2002. Regulation: 8.