MEDTRONIC RESTING HEART SYSTEM, MODEL AAR1000 AND 711

MEDTRONIC RESTING HEART SYSTEM, MODEL AAR1000 AND 711 is an FDA 510(k)-cleared medical device (K031700) manufactured by Medtronic Perfusion Systems. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 28, 2003. Regulation: 8.