MAICO MA800 AUDIOMETER

MAICO MA800 AUDIOMETER is an FDA 510(k)-cleared medical device (K911368) 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 June 25, 1991. Regulation: 8.