510(k) K022909

NIKOMED TRACE 1 ECG ELECTRODES by Nikomed U.S.A., Inc. — Product Code DRX

K022909 is an FDA 510(k) premarket notification submitted by Nikomed U.S.A., Inc. for the device "NIKOMED TRACE 1 ECG ELECTRODES". The FDA issued a decision of Substantially Equivalent on January 9, 2003. The device falls under product code DRX (Electrode, Electrocardiograph), a Class II device regulated under 21 CFR 870.2360. Nikomed U.S.A., Inc. has at least 10 other 510(k) clearances on record.