Luna CPAP and Auto CPAP System

Luna CPAP and Auto CPAP System is an FDA 510(k)-cleared medical device (K153387) 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 September 7, 2016. Regulation: 8.