510(k) K790047

CARDIAC OUTPUT COMPUTER, MDEL 9520A by Edwards Laboratories — Product Code DXG

K790047 is an FDA 510(k) premarket notification submitted by Edwards Laboratories for the device "CARDIAC OUTPUT COMPUTER, MDEL 9520A". The FDA issued a decision of Substantially Equivalent on February 26, 1979. The device falls under product code DXG (Computer, Diagnostic, Pre-Programmed, Single-Function), a Class II device regulated under 21 CFR 870.1435. Edwards Laboratories has at least 10 other 510(k) clearances on record.