Maxtec MaxO2 ME+p

Maxtec MaxO2 ME+p is an FDA 510(k)-cleared medical device (K221734) manufactured by Maxtec, 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 March 31, 2023. Regulation: 8.