TMO TOTAL BYPASS MEMBRANE OXYGENATOR-I

TMO TOTAL BYPASS MEMBRANE OXYGENATOR-I is an FDA 510(k)-cleared medical device (K760824) manufactured by Travenol Laboratories, S.A.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 11, 1976. Regulation: 8.