
Philips Medical Systems
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PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR is an FDA 510(k)-cleared medical device (K130684) 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 October 17, 2013. Regulation: 8.

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