VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY (CCO/SVO2) MONITOR

VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY (CCO/SVO2) MONITOR is an FDA 510(k)-cleared medical device (K955816) manufactured by Baxter Healthcare Corp. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 5, 1997. Regulation: 8.