Cleared Traditional

DAEHAN Adhesive Surface Electrodes

K180247 · Daehan Medical Systems Co., Ltd. · Neurology

Nov 2018

Decision

276d

Days

Class 2

Risk

About This 510(k) Submission

K180247 is an FDA 510(k) clearance for the DAEHAN Adhesive Surface Electrodes, a Electrode, Cutaneous (Class II — Special Controls, product code GXY), submitted by Daehan Medical Systems Co., Ltd. (Siheung-City, KR). The FDA issued a Cleared decision on November 1, 2018, 276 days after receiving the submission on January 29, 2018. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1320.

Submission Details

510(k) Number	K180247 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 29, 2018
Decision Date	November 01, 2018
Days to Decision	276 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF