OMRON MODEL 514N TYMPANIC THERMOMETER

OMRON MODEL 514N TYMPANIC THERMOMETER is an FDA 510(k)-cleared medical device (K051233) manufactured by Omron Healthcare, Inc.. 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 20, 2005. Regulation: 8.