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Medtronic Physio-Control Corp.
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MODIFICATION TO: LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR is an FDA 510(k)-cleared medical device (K012428) manufactured by Medtronic Physio-Control Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on September 27, 2001. Regulation: 8.