
Dantec Electronics, Inc.
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DANTEC 13L40 ST. MARKS'S PUDENDAL ELECTRODE is an FDA 510(k)-cleared medical device (K874758) manufactured by Dantec Electronics, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 13, 1988. Regulation: 8.