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Bio-Detek, Inc.
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PEDI-PADZ RADIOLUCENT MULTI-FUNCTION PEDIATRIC ELECTRODES, MODEL 8900-1005 is an FDA 510(k)-cleared medical device (K040256) manufactured by Bio-Detek, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class III (Premarket Approval) — highest risk category. FDA clearance granted on April 8, 2004. Regulation: 8.