SCIMED MEMBRANE OXYGENATOR, MODEL 0600-2A

SCIMED MEMBRANE OXYGENATOR, MODEL 0600-2A is an FDA 510(k)-cleared medical device (K883053) manufactured by Scimed Life Systems, 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 September 25, 1988. Regulation: 8.