INFRARED EAR THERMOMETER MODEL DR. SCHVEN ICT-1000

INFRARED EAR THERMOMETER MODEL DR. SCHVEN ICT-1000 is an FDA 510(k)-cleared medical device (K100660) 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 October 21, 2010. Regulation: 8.