510(k) K874522

MODIFIED MYOCARDIAL TEMPERATURE SENSOR by Mon-A-Therm, Inc. — Product Code KRB

K874522 is an FDA 510(k) premarket notification submitted by Mon-A-Therm, Inc. for the device "MODIFIED MYOCARDIAL TEMPERATURE SENSOR". The FDA issued a decision of Substantially Equivalent on January 29, 1988. The device falls under product code KRB (Probe, Thermodilution), a Class II device regulated under 21 CFR 870.1915. Mon-A-Therm, Inc. has at least 10 other 510(k) clearances on record.