INFRARED EAR THERMOMETER, MODELS INNOTHERM ICT-100 AND ICT-200

INFRARED EAR THERMOMETER, MODELS INNOTHERM ICT-100 AND ICT-200 is an FDA 510(k)-cleared medical device (K081788) manufactured by Innochips Technology Co., Ltd.. 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 16, 2008. Regulation: 8.