510(k) K884318

THERMOSET(TM) CLOSED LOOP DELIVERY SYSTEM by Abbott Laboratories — Product Code KRB

K884318 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "THERMOSET(TM) CLOSED LOOP DELIVERY SYSTEM". The FDA issued a decision of Substantially Equivalent on December 13, 1988. The device falls under product code KRB (Probe, Thermodilution), a Class II device regulated under 21 CFR 870.1915. Abbott Laboratories has at least 10 other 510(k) clearances on record.