510(k) K161430

Myoject Luer Lock Needle Electrode by Natus Manufacturing Limited — Product Code IKT

K161430 is an FDA 510(k) premarket notification submitted by Natus Manufacturing Limited for the device "Myoject Luer Lock Needle Electrode". The FDA issued a decision of Substantially Equivalent on March 2, 2017. 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.