INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL: 5100C

INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL: 5100C is an FDA 510(k)-cleared medical device (K082327) manufactured by Somanetics 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 April 2, 2009. Regulation: 8.