510(k) K950472

DISPOSABLE ECG MONITORING ELECTRODE #4110 45MM, #4140 35MM by Nikomed U.S.A., Inc. — Product Code DRX

K950472 is an FDA 510(k) premarket notification submitted by Nikomed U.S.A., Inc. for the device "DISPOSABLE ECG MONITORING ELECTRODE #4110 45MM, #4140 35MM". The FDA issued a decision of Substantially Equivalent on November 14, 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.