LIFEPAK 12 DEFIBRILLATOR/MONITOR

LIFEPAK 12 DEFIBRILLATOR/MONITOR is an FDA 510(k)-cleared medical device (K041459) manufactured by Medtronic Emergency Response Systems, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on June 30, 2004. Regulation: 8.