ADULT CEREBRAL OXIMETER, MODEL 2040

ADULT CEREBRAL OXIMETER, MODEL 2040 is an FDA 510(k)-cleared medical device (K051257) 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 December 21, 2005. Regulation: 8.