VIOPTIX ODISSEY TISSUE OXIMETER TISSUE OXIMETER, MODEL OXY-2

VIOPTIX ODISSEY TISSUE OXIMETER TISSUE OXIMETER, MODEL OXY-2 is an FDA 510(k)-cleared medical device (K042657) 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 January 9, 2005. Regulation: 8.