BELTONE ULTIMA 80 OTOSONIC POWER PAS

BELTONE ULTIMA 80 OTOSONIC POWER PAS is an FDA 510(k)-cleared medical device (K954936) manufactured by Beltone Electronics Corp.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on December 5, 1995. Regulation: 8.