PARTNER SEVEN DISP. BUBBLE OXYGENATOR

PARTNER SEVEN DISP. BUBBLE OXYGENATOR is an FDA 510(k)-cleared medical device (K800555) manufactured by Cardiovascular Research, 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 3, 1980. Regulation: 8.