MEDOS HILITE OXYGENATOR

MEDOS HILITE OXYGENATOR is an FDA 510(k)-cleared medical device (K140177) manufactured by Medos Medizintechnik AG. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 17, 2014. Regulation: 8.