510(k) K062437

DISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE VERSION AND PRIVATE LABELED by Technomed Europe — Product Code IKT

K062437 is an FDA 510(k) premarket notification submitted by Technomed Europe for the device "DISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE VERSION AND PRIVATE LABELED". The FDA issued a decision of Substantially Equivalent on February 16, 2007. The device falls under product code IKT (Electrode, Needle, Diagnostic Electromyograph), a Class II device regulated under 21 CFR 890.1385. Technomed Europe has at least 10 other 510(k) clearances on record.