TDR-4S MONAURAL HEARING AID/WIRELESS FM RECEIVER

TDR-4S MONAURAL HEARING AID/WIRELESS FM RECEIVER is an FDA 510(k)-cleared medical device (K915384) manufactured by Telex Communications, 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 January 16, 1992. Regulation: 8.