AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)

AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES) is an FDA 510(k)-cleared medical device (K010462) 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 April 10, 2001. Regulation: 8.