TEMPTELLER INFARED EAR THERMOMETERS, MODEL CT-31/31DX/32/32DX

TEMPTELLER INFARED EAR THERMOMETERS, MODEL CT-31/31DX/32/32DX is an FDA 510(k)-cleared medical device (K030299) 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 February 24, 2003. Regulation: 8.