T-Stat 2.0 Microvascular Tissue Oximeter

T-Stat 2.0 Microvascular Tissue Oximeter is an FDA 510(k)-cleared medical device (K192322) 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 September 22, 2019. Regulation: 8.