DISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE VERSION AND PRIVATE LABELED

About This 510(k) Submission

K062437 is an FDA 510(k) clearance for the DISPOSABLE HYPODERMIC EMG NEEDLE ELECTRODE TECHNOMED EUROPE VERSION AND PRIVATE LABELED, a Electrode, Needle, Diagnostic Electromyograph (Class II — Special Controls, product code IKT), submitted by Technomed Europe (Maastricht-Airport, NL). The FDA issued a Cleared decision on February 16, 2007, 189 days after receiving the submission on August 11, 2006. This device falls under the Neurology review panel. Regulated under 21 CFR 890.1385.