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Zoll Medical Corp
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ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC) is an FDA 510(k)-cleared medical device (K032439) manufactured by Zoll Medical Corp. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on November 4, 2003. Regulation: 8.