BIVONA FOME-CUF(R) & AIR CUF(R), MODIFICATION

BIVONA FOME-CUF(R) & AIR CUF(R), MODIFICATION is an FDA 510(k)-cleared medical device (K913859) 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 29, 1992. Regulation: 8.