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Philips Medical Systems
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HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735A is an FDA 510(k)-cleared medical device (K021453) 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 July 2, 2002. Regulation: 8.