EAR ELECTRODE-ADULT & PEDIATRIC

EAR ELECTRODE-ADULT & PEDIATRIC is an FDA 510(k)-cleared medical device (K780537) manufactured by Life-Tech Instruments, 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 June 1, 1978. Regulation: 8.