510(k) K130136

DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES, by Technomed Europe — Product Code GXZ

K130136 is an FDA 510(k) premarket notification submitted by Technomed Europe for the device "DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES,". The FDA issued a decision of Substantially Equivalent on July 19, 2013. The device falls under product code GXZ (Electrode, Needle), a Class II device regulated under 21 CFR 882.1350. Technomed Europe has at least 10 other 510(k) clearances on record.