COCHLEA-SCAN / COCHLEA-SCAN PLUS

COCHLEA-SCAN / COCHLEA-SCAN PLUS is an FDA 510(k)-cleared medical device (K061744) manufactured by Bio-Logic Systems Corp.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 14, 2006. Regulation: 8.