510(k) K812757

SORENSON THERMODILUTION CARDIAC COMPUT by Sorensen Research — Product Code DXG

K812757 is an FDA 510(k) premarket notification submitted by Sorensen Research for the device "SORENSON THERMODILUTION CARDIAC COMPUT". The FDA issued a decision of Substantially Equivalent on November 2, 1981. The device falls under product code DXG (Computer, Diagnostic, Pre-Programmed, Single-Function), a Class II device regulated under 21 CFR 870.1435. Sorensen Research has at least 10 other 510(k) clearances on record.