THE MONITOR/DEMLAR MODEL MI-5000 AUDIOMETER

THE MONITOR/DEMLAR MODEL MI-5000 AUDIOMETER is an FDA 510(k)-cleared medical device (K913356) manufactured by Monitor 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 December 4, 1991. Regulation: 8.