COBE OXYGENATOR PRODUCTS

COBE OXYGENATOR PRODUCTS is an FDA 510(k)-cleared medical device (K974085) manufactured by Cobe Cardiovascular, 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 January 26, 1998. Regulation: 8.