A BAER WITH ABAER I/O FUNCTION

A BAER WITH ABAER I/O FUNCTION is an FDA 510(k)-cleared medical device (K112247) manufactured by Natus Medical Incorporated. 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 1, 2012. Regulation: 8.