BIVONA TRACHEOSTOMA VALVE II

BIVONA TRACHEOSTOMA VALVE II is an FDA 510(k)-cleared medical device (K852272) 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 7, 1985. Regulation: 8.