BEHIND-THE-EAR MASKING AMPLIFIER,735S

BEHIND-THE-EAR MASKING AMPLIFIER,735S is an FDA 510(k)-cleared medical device (K780546) manufactured by Danavox, Inc.. 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 April 9, 1978. Regulation: 8.