DANPLEX SCREENING AUDIOMETER

DANPLEX SCREENING AUDIOMETER is an FDA 510(k)-cleared medical device (K923074) manufactured by Life-Tech Intl., 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 September 22, 1992. Regulation: 8.