INFRARED EAR THERMOMETER, MODELS TH88 SERIES

INFRARED EAR THERMOMETER, MODELS TH88 SERIES is an FDA 510(k)-cleared medical device (K020504) manufactured by Radiant Innovation, 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 February 27, 2002. Regulation: 8.