510(k) K850107

CONCENTRIC NEEDLE ELECTRODES-VARIOUS SIZES W/CONNE by Nicolet Biomedical Instruments — Product Code GXZ

K850107 is an FDA 510(k) premarket notification submitted by Nicolet Biomedical Instruments for the device "CONCENTRIC NEEDLE ELECTRODES-VARIOUS SIZES W/CONNE". The FDA issued a decision of Substantially Equivalent on April 11, 1985. The device falls under product code GXZ (Electrode, Needle), a Class II device regulated under 21 CFR 882.1350. Nicolet Biomedical Instruments has at least 10 other 510(k) clearances on record.