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Access Cardiosystems, Inc.
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ACCESSAED, SEMI-AUTOMATIC EXTERNAL DEFIBRILLATORS is an FDA 510(k)-cleared medical device (K020984) manufactured by Access Cardiosystems, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on August 13, 2002. Regulation: 8.