MODIFIED JELTRODE(TM) ELECTRODES DEEMED

MODIFIED JELTRODE(TM) ELECTRODES DEEMED is an FDA 510(k)-cleared medical device (K884348) manufactured by Henley Intl.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 14, 1988. Regulation: 8.