BIVONA(R) ICU ENDOTRACHEAL TUBE

BIVONA(R) ICU ENDOTRACHEAL TUBE is an FDA 510(k)-cleared medical device (K931749) 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 August 9, 1993. Regulation: 8.