Therapy Mask 3100 NC/SP

Therapy Mask 3100 NC/SP is an FDA 510(k)-cleared medical device (K231313) 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 July 27, 2023. Regulation: 8.