510(k) K950477

DISPOSABLE ECG MONITORING ELECTRODE #4560 38X60MM by Nikomed U.S.A., Inc. — Product Code DRX

K950477 is an FDA 510(k) premarket notification submitted by Nikomed U.S.A., Inc. for the device "DISPOSABLE ECG MONITORING ELECTRODE #4560 38X60MM". The FDA issued a decision of Substantially Equivalent on November 6, 1995. 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.