SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)

SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS) is an FDA 510(k)-cleared medical device (K971628) 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 October 9, 1997. Regulation: 8.