REVOLUTION FULLFACE MASK

REVOLUTION FULLFACE MASK is an FDA 510(k)-cleared medical device (K140580) manufactured by Respironics Inc. (Dba Philips Respironics). This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 15, 2015. Regulation: 8.