THE INFRARED FOREHEAD THERMOMETER, MODEL FS-300&301

THE INFRARED FOREHEAD THERMOMETER, MODEL FS-300&301 is an FDA 510(k)-cleared medical device (K101912) manufactured by Hubdic 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 November 9, 2010. Regulation: 8.