DreamWear Silicone Pillows Mask

DreamWear Silicone Pillows Mask is an FDA 510(k)-cleared medical device (K210844) manufactured by Respironics, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 23, 2021. Regulation: 8.