INOmax DSIR Plus MRI

INOmax DSIR Plus MRI is an FDA 510(k)-cleared medical device (K143213) manufactured by Ino Therapeutics/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 July 9, 2015. Regulation: 8.