SCREENING AUDIOMETRY WORD RECOGNITION AUDIOMETRY

SCREENING AUDIOMETRY WORD RECOGNITION AUDIOMETRY is an FDA 510(k)-cleared medical device (K950888) manufactured by Calmed Technology, 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 March 20, 1995. Regulation: 8.