INTRA. OX HANDHELD TISSUE OXIMETER

INTRA. OX HANDHELD TISSUE OXIMETER is an FDA 510(k)-cleared medical device (K133983) 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 11, 2014. Regulation: 8.