
Philips Medical Systems
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PHILIPS HEARTSTART FRX DEFIBRILLATOR, MODEL 861304 is an FDA 510(k)-cleared medical device (K050004) 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 February 24, 2005. Regulation: 8.