TEMP TELLER-INFRARED TYMPANIC THERMOMETER, MODELS TT-200, TT-201

TEMP TELLER-INFRARED TYMPANIC THERMOMETER, MODELS TT-200, TT-201 is an FDA 510(k)-cleared medical device (K984497) manufactured by Oriental System Technology, 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 May 25, 1999. Regulation: 8.