The Braun ThermoScan® 3 High Speed Compact Ear Thermometer

The Braun ThermoScan® 3 High Speed Compact Ear Thermometer is an FDA 510(k)-cleared medical device (K161933) manufactured by Kaz USA, Inc., A Helen of Troy Company. 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 August 15, 2016. Regulation: 8.