MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT

MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT is an FDA 510(k)-cleared medical device (K081516) manufactured by Medsource International, 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 August 25, 2008. Regulation: 8.