
Defibtech, LLC
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DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES is an FDA 510(k)-cleared medical device (K113787) 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 January 3, 2013. Regulation: 8.