SPORT/AUDX OAE TEST INSTRUMENT WITH BIO-LOGIC EAR PROBE

SPORT/AUDX OAE TEST INSTRUMENT WITH BIO-LOGIC EAR PROBE is an FDA 510(k)-cleared medical device (K974076) 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 January 21, 1998. Regulation: 8.