510(k) K872529

THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2 by American Edwards Laboratories — Product Code DXG

K872529 is an FDA 510(k) premarket notification submitted by American Edwards Laboratories for the device "THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2". The FDA issued a decision of Substantially Equivalent on September 15, 1987. The device falls under product code DXG (Computer, Diagnostic, Pre-Programmed, Single-Function), a Class II device regulated under 21 CFR 870.1435. American Edwards Laboratories has at least 10 other 510(k) clearances on record.