DATATHERM II CONTINUOUS TEMPERATURE MONITOR, MODEL KD-2300

DATATHERM II CONTINUOUS TEMPERATURE MONITOR, MODEL KD-2300 is an FDA 510(k)-cleared medical device (K070878) manufactured by Rg Medical Diagnostics. 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 June 4, 2007. Regulation: 8.