MA630 IMPED SCREENER/MA640 IMPED/AUDIOMET SCREENER

MA630 IMPED SCREENER/MA640 IMPED/AUDIOMET SCREENER is an FDA 510(k)-cleared medical device (K905704) 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 April 29, 1991. Regulation: 8.