ER35 ERO-SCAN PRO HEARING TEST SYSTEM

ER35 ERO-SCAN PRO HEARING TEST SYSTEM is an FDA 510(k)-cleared medical device (K070880) manufactured by Etymotic Research, 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 6, 2007. Regulation: 8.