DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19)

DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19) is an FDA 510(k)-cleared medical device (K950314) manufactured by Dantec Medical, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 24, 1996. Regulation: 8.