Luna® G3 BPAP 25A

Luna® G3 BPAP 25A is an FDA 510(k)-cleared medical device (K201620) manufactured by 3B Medical, 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 January 28, 2021. Regulation: 8.