OXYGENATORS #BOS-10, 105, 5S

OXYGENATORS #BOS-10, 105, 5S is an FDA 510(k)-cleared medical device (K823456) manufactured by Bentley Laboratories, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 29, 1982. Regulation: 8.