ONESTEP CPR II MULTI-FUNCTION ELECTRODE

ONESTEP CPR II MULTI-FUNCTION ELECTRODE is an FDA 510(k)-cleared medical device (K133441) manufactured by Bio-Detek, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on October 9, 2014. Regulation: 8.