AVITA SCANEO IR THERMOMETER, MODELS TS2X & TS3X SERIES

AVITA SCANEO IR THERMOMETER, MODELS TS2X & TS3X SERIES is an FDA 510(k)-cleared medical device (K092958) manufactured by Avita Corporation. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 1, 2009. Regulation: 8.