AVITA TS8/TS9 SERIES IR EAR/FOREHEAD THERMOMETER

AVITA TS8/TS9 SERIES IR EAR/FOREHEAD THERMOMETER is an FDA 510(k)-cleared medical device (K031503) manufactured by Avita Corporation. 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 October 23, 2003. Regulation: 8.