MEDOS HILITE 7000 & 7000 LT OXYGENATOR

MEDOS HILITE 7000 & 7000 LT OXYGENATOR is an FDA 510(k)-cleared medical device (K133261) 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 January 8, 2014. Regulation: 8.