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Philips Medical Systems
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HEARTSTREAM/HEARTSTART FR2 AED ECG CABLE, MODELS M3860A, M3861A, M3840A, M3841A is an FDA 510(k)-cleared medical device (K013425) 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 13, 2002. Regulation: 8.