BIVONA HYPERFLEX TRACHEOSTOMY TUBE

BIVONA HYPERFLEX TRACHEOSTOMY TUBE is an FDA 510(k)-cleared medical device (K922665) 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 January 6, 1993. Regulation: 8.