MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DE1-1

MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DE1-1 is an FDA 510(k)-cleared medical device (K034023) manufactured by Microlife Intellectual Property GmbH. 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 14, 2004. Regulation: 8.