Cleared Traditional

DAEHAN Disposable CUP Electrodes

K180232 · Daehan Medical Systems Co., Ltd. · Neurology

Apr 2019

Decision

429d

Days

Class 2

Risk

About This 510(k) Submission

K180232 is an FDA 510(k) clearance for the DAEHAN Disposable CUP 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 April 3, 2019, 429 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	K180232 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 29, 2018
Decision Date	April 03, 2019
Days to Decision	429 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF