BigEasy Non-Rebreathing Valve

BigEasy Non-Rebreathing Valve is an FDA 510(k)-cleared medical device (K142402) manufactured by 12th Man Technologies, 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 March 22, 2015. Regulation: 8.