BIVONA AIRE-CUF TRACHEOSTOMY TUBE W/TALK ATTACH.

BIVONA AIRE-CUF TRACHEOSTOMY TUBE W/TALK ATTACH. is an FDA 510(k)-cleared medical device (K912967) 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 July 16, 1991. Regulation: 8.