HEARTSTART MRX, MODELS M3535A OR M3536A

HEARTSTART MRX, MODELS M3535A OR M3536A is an FDA 510(k)-cleared medical device (K063375) manufactured by Philips Medical Systems. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on January 10, 2007. Regulation: 8.