510(k) K840439

RECOMED CARDIAC OUTPUT METER 236067- by Litton Medical Electronics — Product Code DXG

K840439 is an FDA 510(k) premarket notification submitted by Litton Medical Electronics for the device "RECOMED CARDIAC OUTPUT METER 236067-". The FDA issued a decision of Substantially Equivalent on November 20, 1984. The device falls under product code DXG (Computer, Diagnostic, Pre-Programmed, Single-Function), a Class II device regulated under 21 CFR 870.1435. Litton Medical Electronics has at least 10 other 510(k) clearances on record.