AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON

AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON is an FDA 510(k)-cleared medical device (K121793) manufactured by Audifon-USA, 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 October 31, 2012. Regulation: 8.