SCREENING AUDIOMETER, HIGH FREQUENCY

SCREENING AUDIOMETER, HIGH FREQUENCY is an FDA 510(k)-cleared medical device (K790878) manufactured by Vicon Instrument Co.. 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 August 2, 1979. Regulation: 8.