HEARID+TE TRANSIENT-EVOKED OTOACOUSTIC EMISSIONS ANALYZER

HEARID+TE TRANSIENT-EVOKED OTOACOUSTIC EMISSIONS ANALYZER is an FDA 510(k)-cleared medical device (K063338) manufactured by Mimosa Acoustics, 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 January 3, 2007. Regulation: 8.