OPUS 2 - FULL CONCHA SERIES - ITE

OPUS 2 - FULL CONCHA SERIES - ITE is an FDA 510(k)-cleared medical device (K974211) manufactured by Bernafon-Maico, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on December 14, 1997. Regulation: 8.