510(k) K091410

DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT, by Spes Medica Srl — Product Code IKT

K091410 is an FDA 510(k) premarket notification submitted by Spes Medica Srl for the device "DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT,". The FDA issued a decision of Substantially Equivalent on August 11, 2009. The device falls under product code IKT (Electrode, Needle, Diagnostic Electromyograph), a Class II device regulated under 21 CFR 890.1385. Spes Medica Srl has at least 8 other 510(k) clearances on record.