SHILEY S-100A (ADULT) BLOOD OXYGENATOR

SHILEY S-100A (ADULT) BLOOD OXYGENATOR is an FDA 510(k)-cleared medical device (K810470) manufactured by Shiley, 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 April 16, 1981. Regulation: 8.