510(k) K781805

CARDIAC COMPUTERS, CO-10 & CO-10R by Waters Assoc., Inc. — Product Code DXG

K781805 is an FDA 510(k) premarket notification submitted by Waters Assoc., Inc. for the device "CARDIAC COMPUTERS, CO-10 & CO-10R". The FDA issued a decision of Substantially Equivalent on January 29, 1979. The device falls under product code DXG (Computer, Diagnostic, Pre-Programmed, Single-Function), a Class II device regulated under 21 CFR 870.1435. Waters Assoc., Inc. has at least 10 other 510(k) clearances on record.