MIRACLE-EAR MODEL PGF + REMOTE

MIRACLE-EAR MODEL PGF + REMOTE is an FDA 510(k)-cleared medical device (K942893) manufactured by Miracle-Ear/Dahlberg, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on August 16, 1994. Regulation: 8.