PERFORMAX SE TOTAL FACE MASK

PERFORMAX SE TOTAL FACE MASK is an FDA 510(k)-cleared medical device (K072588) manufactured by Respironics Inc., Sleep & Home Respiratory Group. 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 17, 2007. Regulation: 8.