BIVONA AIRE-CUF ADJUSTABLE TRACHEOSTOMY TUBE

BIVONA AIRE-CUF ADJUSTABLE TRACHEOSTOMY TUBE is an FDA 510(k)-cleared medical device (K894614) manufactured by Bivona Medical Technologies. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 12, 1989. Regulation: 8.