EAR THERMOMETER, MODELS ST613C AND ST613F

EAR THERMOMETER, MODELS ST613C AND ST613F is an FDA 510(k)-cleared medical device (K011254) manufactured by Mesure Technology. 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 July 9, 2001. Regulation: 8.