MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IRIDVI-1

MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IRIDVI-1 is an FDA 510(k)-cleared medical device (K091040) 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 May 12, 2009. Regulation: 8.