Cleared Traditional

GEMORE REUSEABLE SELF ADHESIVE ELECTRODE, MODELS WIRE SERIES, SNAP SERIES AND DOUBLE SIDE SERIES

K062675 · Gemore Technology Co, Ltd. · Neurology

Jan 2007

Decision

118d

Days

Class 2

Risk

About This 510(k) Submission

K062675 is an FDA 510(k) clearance for the GEMORE REUSEABLE SELF ADHESIVE ELECTRODE, MODELS WIRE SERIES, SNAP SERIES AND DOUBLE SIDE SERIES, a Electrode, Cutaneous (Class II — Special Controls, product code GXY), submitted by Gemore Technology Co, Ltd. (Tan Shui, New Taipei City, TW). The FDA issued a Cleared decision on January 4, 2007, 118 days after receiving the submission on September 8, 2006. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1320.

Submission Details

510(k) Number	K062675 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 08, 2006
Decision Date	January 04, 2007
Days to Decision	118 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF