510(k) K834408

TX-2 THERMAL DILUTION CARDIAC OUTPUT by Waters Instruments, Inc. — Product Code DXG

K834408 is an FDA 510(k) premarket notification submitted by Waters Instruments, Inc. for the device "TX-2 THERMAL DILUTION CARDIAC OUTPUT". The FDA issued a decision of Substantially Equivalent on August 23, 1984. The device falls under product code DXG (Computer, Diagnostic, Pre-Programmed, Single-Function), a Class II device regulated under 21 CFR 870.1435. Waters Instruments, Inc. has at least 10 other 510(k) clearances on record.