PHONIC EAR, PE 860C, PE 860PPC AND PE 860 PPCL

PHONIC EAR, PE 860C, PE 860PPC AND PE 860 PPCL is an FDA 510(k)-cleared medical device (K874304) manufactured by Phonic Ear, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on November 19, 1987. Regulation: 8.