ILO292 DP ECHOPORT PLUS OAE SYSTEM

ILO292 DP ECHOPORT PLUS OAE SYSTEM is an FDA 510(k)-cleared medical device (K983350) manufactured by Otodynamics, Ltd.. 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 10, 1998. Regulation: 8.