510(k) K143433

Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable Concentric Needle Electrodes-37mm, Dantec DCN Disposable Concentric Needle Electrodes-50mm, Dantec DCN Disposable Concentric Needle Electrodes-75mm by Natus Manufacturing Limited — Product Code IKT

K143433 is an FDA 510(k) premarket notification submitted by Natus Manufacturing Limited for the device "Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable Concentric Needle Electrodes-37mm, Dantec DCN Disposable Concentric Needle Electrodes-50mm, Dantec DCN Disposable Concentric Needle Electrodes-75mm". The FDA issued a decision of Substantially Equivalent on August 28, 2015. The device falls under product code IKT (Electrode, Needle, Diagnostic Electromyograph), a Class II device regulated under 21 CFR 890.1385. Natus Manufacturing Limited has at least 3 other 510(k) clearances on record.