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Ino Therapeutics, LLC/Dba Ikaria
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INOMAX DS(IR) (DELIVERY SYSTEM) is an FDA 510(k)-cleared medical device (K110635) 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 June 22, 2011. Regulation: 8.