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Zoll Medical Corporation, World Wide Headquarters
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ZOLL R SERIES WITH 2010 AHA GUIDELINES SOFTWARE UPDATE is an FDA 510(k)-cleared medical device (K110361) manufactured by Zoll Medical Corporation, World Wide Headquarters. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on March 7, 2011. Regulation: 8.