SleepWeaver 3D Nasal Mask

SleepWeaver 3D Nasal Mask is an FDA 510(k)-cleared medical device (K162905) 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 March 14, 2017. Regulation: 8.