WIDEX MODEL Q12 BTE WITH QUATRO REMOTE CONTROL

WIDEX MODEL Q12 BTE WITH QUATRO REMOTE CONTROL is an FDA 510(k)-cleared medical device (K901317) manufactured by Widex Hearing Aid Co., Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on April 9, 1990. Regulation: 8.