FORE-SIGHT CEREBRAL OXIMETER MONITOR, MODEL 2040

FORE-SIGHT CEREBRAL OXIMETER MONITOR, MODEL 2040 is an FDA 510(k)-cleared medical device (K061960) manufactured by Cas Medical 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 4, 2006. Regulation: 8.