GISH RELIANCE OXYGENATOR (MODEL HFO)

GISH RELIANCE OXYGENATOR (MODEL HFO) is an FDA 510(k)-cleared medical device (K961530) manufactured by Gish Biomedical, 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 4, 1996. Regulation: 8.