FOME-CUF-WIRE RE-ENFORCED, AIRE-CUF WIRE

FOME-CUF-WIRE RE-ENFORCED, AIRE-CUF WIRE is an FDA 510(k)-cleared medical device (K792035) 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 October 25, 1979. Regulation: 8.