510(k) K152984

Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes by Bio Protech, Inc. — Product Code IKT

K152984 is an FDA 510(k) premarket notification submitted by Bio Protech, Inc. for the device "Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes". The FDA issued a decision of Substantially Equivalent on June 3, 2016. The device falls under product code IKT (Electrode, Needle, Diagnostic Electromyograph), a Class II device regulated under 21 CFR 890.1385. Bio Protech, Inc. has at least 10 other 510(k) clearances on record.