O2 Concepts Oxlife Independence Model 301-0001

O2 Concepts Oxlife Independence Model 301-0001 is an FDA 510(k)-cleared medical device (K182454) manufactured by O2 Concepts, 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 December 19, 2018. Regulation: 8.