510(k) K093825

AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE by Ambu A/S — Product Code IKT

K093825 is an FDA 510(k) premarket notification submitted by Ambu A/S for the device "AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE". The FDA issued a decision of Substantially Equivalent on January 13, 2010. The device falls under product code IKT (Electrode, Needle, Diagnostic Electromyograph), a Class II device regulated under 21 CFR 890.1385. Ambu A/S has at least 10 other 510(k) clearances on record.