CUP ELECTRODES, GOLD, REUSABLE, SILVER, REUSABLE; CUP ELECTRODES SILVER/SILVER CHLORIDE REUSABLE

About This 510(k) Submission

K072016 is an FDA 510(k) clearance for the CUP ELECTRODES, GOLD, REUSABLE, SILVER, REUSABLE; CUP ELECTRODES SILVER/SILVER CHLORIDE REUSABLE, a Electrode, Cutaneous (Class II — Special Controls, product code GXY), submitted by Technomed Europe (Maastricht-Airport, NL). The FDA issued a Cleared decision on October 19, 2007, 88 days after receiving the submission on July 23, 2007. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1320.