SLEEPWEAVER ANEW FULL FACE SOFT CLOTH PAP MASK

SLEEPWEAVER ANEW FULL FACE SOFT CLOTH PAP MASK is an FDA 510(k)-cleared medical device (K130481) manufactured by Circadiance, LLC. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 23, 2013. Regulation: 8.