THERMO PAL INFRARED EAR THERMOMETER

THERMO PAL INFRARED EAR THERMOMETER is an FDA 510(k)-cleared medical device (K112189) manufactured by Digio2 International 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 January 12, 2012. Regulation: 8.