SARNS SM03 MEMBRANE OXYGENATOR W/ INTEGRATED RESER

SARNS SM03 MEMBRANE OXYGENATOR W/ INTEGRATED RESER is an FDA 510(k)-cleared medical device (K912920) manufactured by 3M Health Care, Ltd.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 24, 1991. Regulation: 8.