COMFORTGEL NASAL MASK

COMFORTGEL NASAL MASK is an FDA 510(k)-cleared medical device (K092835) 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 February 11, 2010. Regulation: 8.