ORBITER 922 CLINICAL AUDIOMETER

ORBITER 922 CLINICAL AUDIOMETER is an FDA 510(k)-cleared medical device (K931324) manufactured by Madsen Electronics (Canada) , Ltd.. 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 November 18, 1993. Regulation: 8.