SPIRAFLO BLOOD OXYGENATORS MODEL BOS-10S

SPIRAFLO BLOOD OXYGENATORS MODEL BOS-10S is an FDA 510(k)-cleared medical device (K802719) 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 15, 1980. Regulation: 8.