Intra.Ox 2.0 Handheld Tissue Oximeter

Intra.Ox 2.0 Handheld Tissue Oximeter is an FDA 510(k)-cleared medical device (K191676) manufactured by Vioptix, 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 September 15, 2019. Regulation: 8.