BIVONA ECONOMY DUCKBILL VOICE PROSTHESIS

BIVONA ECONOMY DUCKBILL VOICE PROSTHESIS is an FDA 510(k)-cleared medical device (K861088) manufactured by Bivona Medical Technologies. 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 1, 1986. Regulation: 8.