INOMAX DS(DELIVERY SYSTEMS

INOMAX DS(DELIVERY SYSTEMS is an FDA 510(k)-cleared medical device (K113272) manufactured by Ino Therapeutics, LLC/Dba Ikaria. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 28, 2012. Regulation: 8.