SARNS SMOC MEMBRANE OXY W/INTEGRAT CARD RES,MODIFY

SARNS SMOC MEMBRANE OXY W/INTEGRAT CARD RES,MODIFY is an FDA 510(k)-cleared medical device (K912079) manufactured by 3M Health Care, Sarns. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 22, 1991. Regulation: 8.