HEARTSTREAM FR2 AED, MODEL M3860A,M3861A

HEARTSTREAM FR2 AED, MODEL M3860A,M3861A is an FDA 510(k)-cleared medical device (K003565) manufactured by Agilent Technologies, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on December 19, 2000. Regulation: 8.