510(k) K841967

DESERET THERMODILUTION CARDIAC OUTPUT by Parke-Davis Co. — Product Code DXG

K841967 is an FDA 510(k) premarket notification submitted by Parke-Davis Co. for the device "DESERET THERMODILUTION CARDIAC OUTPUT". The FDA issued a decision of Substantially Equivalent on August 19, 1985. The device falls under product code DXG (Computer, Diagnostic, Pre-Programmed, Single-Function), a Class II device regulated under 21 CFR 870.1435. Parke-Davis Co. has at least 10 other 510(k) clearances on record.