BI-TEMP TEMPERATURE MONITOR, MODEL TM-400D

BI-TEMP TEMPERATURE MONITOR, MODEL TM-400D is an FDA 510(k)-cleared medical device (K912280) manufactured by Respiratory Support Products, 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 October 16, 1991. Regulation: 8.