510(k) K874605

HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR by Mallinckrodt Critical Care — Product Code KRI

K874605 is an FDA 510(k) premarket notification submitted by Mallinckrodt Critical Care for the device "HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR". The FDA issued a decision of Substantially Equivalent on February 2, 1988. The device falls under product code KRI (Accessory Equipment, Cardiopulmonary Bypass), a Class I device regulated under 21 CFR 870.4200. Mallinckrodt Critical Care has at least 10 other 510(k) clearances on record.