510(k) K011818

STERILE EMG ELECTRODES by Nicolet Biomedical, Inc. — Product Code IKT

K011818 is an FDA 510(k) premarket notification submitted by Nicolet Biomedical, Inc. for the device "STERILE EMG ELECTRODES". The FDA issued a decision of Substantially Equivalent on September 6, 2001. The device falls under product code IKT (Electrode, Needle, Diagnostic Electromyograph), a Class II device regulated under 21 CFR 890.1385. Nicolet Biomedical, Inc. has at least 10 other 510(k) clearances on record.