MICROLIFE DIGITAL INFRARED FOREHEAD THERMOMETER, MODEL FR1DM1

MICROLIFE DIGITAL INFRARED FOREHEAD THERMOMETER, MODEL FR1DM1 is an FDA 510(k)-cleared medical device (K033820) 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 February 22, 2004. Regulation: 8.