
Philips Medical Systems North America, Inc.
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HEARTSTART MRX MONITOR/DEFIBRILLATOR is an FDA 510(k)-cleared medical device (K062233) manufactured by Philips Medical Systems North America, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on November 21, 2006. Regulation: 8.