SCIMED ULTROX TRUE MEMBRANE OXYGEN SYST, ULTROX II

SCIMED ULTROX TRUE MEMBRANE OXYGEN SYST, ULTROX II is an FDA 510(k)-cleared medical device (K894103) 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 20, 1989. Regulation: 8.