EXACON THERMOMETER SYSTEM 8000

EXACON THERMOMETER SYSTEM 8000 is an FDA 510(k)-cleared medical device (K821555) manufactured by Sat Export Engineering & Trading. 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 August 15, 1982. Regulation: 8.