TINNITUS MASKERS, MODELS S564&S574

TINNITUS MASKERS, MODELS S564&S574 is an FDA 510(k)-cleared medical device (K771769) manufactured by Vicon Instrument Co.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 2, 1978. Regulation: 8.