IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2

IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2 is an FDA 510(k)-cleared medical device (K131901) manufactured by 3B Medical, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 22, 2013. Regulation: 8.