MICROLIFE DIGITAL ELECTRONIC THERMOMETER, MODEL MT16K1

MICROLIFE DIGITAL ELECTRONIC THERMOMETER, MODEL MT16K1 is an FDA 510(k)-cleared medical device (K091589) 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 June 9, 2009. Regulation: 8.