SULLIVAN MIRAGE FULL FACE MASK

SULLIVAN MIRAGE FULL FACE MASK is an FDA 510(k)-cleared medical device (K982530) manufactured by Resmed, Ltd.. 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 15, 1998. Regulation: 8.