TEMPTELLER INFRARED EAR THERMOMETER, MODELS TT-901, TT-911 AND TT-921

TEMPTELLER INFRARED EAR THERMOMETER, MODELS TT-901, TT-911 AND TT-921 is an FDA 510(k)-cleared medical device (K001008) 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 April 11, 2000. Regulation: 8.