EVOMATIC 8000/4000

EVOMATIC 8000/4000 is an FDA 510(k)-cleared medical device (K843815) manufactured by Dantec Electronics, 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 May 30, 1985. Regulation: 8.