T-STAT MICROVASCULAR TISSUE OXIMETER, MODEL 303

T-STAT MICROVASCULAR TISSUE OXIMETER, MODEL 303 is an FDA 510(k)-cleared medical device (K040684) manufactured by Spectros Corporation. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 4, 2004. Regulation: 8.