KS 5 - CLINICAL AUDIOMETER

KS 5 - CLINICAL AUDIOMETER is an FDA 510(k)-cleared medical device (K931322) manufactured by Maico Hearing Instruments, 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 August 18, 1994. Regulation: 8.