
Bio-Detek, Inc.
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BIO-DETEK MODIFIED ADULT MULTI-FUNCTION ELECTRODE WITH CONNECTOR is an FDA 510(k)-cleared medical device (K033771) 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 February 26, 2004. Regulation: 8.