INDICATENS INDICATOR ELECTRODE MODEL 2

INDICATENS INDICATOR ELECTRODE MODEL 2 is an FDA 510(k)-cleared medical device (K891107) manufactured by Acudata Software. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 24, 1989. Regulation: 8.