AMER. BENTLEY OXYGENATOR MAX-10 W/SMOOTH HEAT EXCH

AMER. BENTLEY OXYGENATOR MAX-10 W/SMOOTH HEAT EXCH is an FDA 510(k)-cleared medical device (K844901) manufactured by American Bentley. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 6, 1985. Regulation: 8.