EXTRACORPOREAL BLOOD GAS SYSTEM

EXTRACORPOREAL BLOOD GAS SYSTEM is an FDA 510(k)-cleared medical device (K822000) manufactured by Cardiovascular Devices, 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 21, 1982. Regulation: 8.