EASYTEM DUO, FOREHEAD/EAR THERMOMETER, MODEL BT-021

EASYTEM DUO, FOREHEAD/EAR THERMOMETER, MODEL BT-021 is an FDA 510(k)-cleared medical device (K033077) manufactured by Metatech Co., Ltd.. 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 29, 2004. Regulation: 8.