GENIUS 2 INFRARED TYMPANIC ELECTRONIC THERMOMETER, MODEL 303000

GENIUS 2 INFRARED TYMPANIC ELECTRONIC THERMOMETER, MODEL 303000 is an FDA 510(k)-cleared medical device (K060649) manufactured by Tyco Healthcare Group LP. 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 21, 2006. Regulation: 8.