HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR

HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR is an FDA 510(k)-cleared medical device (K874605) manufactured by Mallinckrodt Critical Care. This device is classified under the Cardiovascular specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on February 1, 1988. Regulation: 8.