510(k) K142470

E-Shield Multi-paried Subdermal Needle Electrodes by Neuroinvent, Inc. — Product Code GXZ

K142470 is an FDA 510(k) premarket notification submitted by Neuroinvent, Inc. for the device "E-Shield Multi-paried Subdermal Needle Electrodes". The FDA issued a decision of Substantially Equivalent on November 5, 2014. The device falls under product code GXZ (Electrode, Needle), a Class II device regulated under 21 CFR 882.1350. Neuroinvent, Inc. has at least 1 other 510(k) clearance on record.