OXYGENATOR, BLOOD BOS-10

OXYGENATOR, BLOOD BOS-10 is an FDA 510(k)-cleared medical device (K781842) 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 November 7, 1978. Regulation: 8.