BIVONA SLEEP APNEA TUBE

BIVONA SLEEP APNEA TUBE is an FDA 510(k)-cleared medical device (K915799) 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 February 2, 1992. Regulation: 8.