TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC

TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC is an FDA 510(k)-cleared medical device (K974751) manufactured by General Hearing Instruments, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on March 5, 1998. Regulation: 8.