VISUAL REINFORCE. AUDIO CASSETTE UNIT: BASIC & ADV

VISUAL REINFORCE. AUDIO CASSETTE UNIT: BASIC & ADV is an FDA 510(k)-cleared medical device (K880259) manufactured by Colorado Hearing Systems, Inc.. 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 April 2, 1989. Regulation: 8.