Cleared Traditional

DMS Disposable Subdermal Needle Electrodes

K161566 · Daehan Medical Systems Co., Ltd. · Neurology

Dec 2016

Decision

198d

Days

Class 2

Risk

About This 510(k) Submission

K161566 is an FDA 510(k) clearance for the DMS Disposable Subdermal Needle Electrodes, a Electrode, Needle (Class II — Special Controls, product code GXZ), submitted by Daehan Medical Systems Co., Ltd. (Siheung-City, KR). The FDA issued a Cleared decision on December 21, 2016, 198 days after receiving the submission on June 6, 2016. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1350.

Submission Details

510(k) Number	K161566 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 06, 2016
Decision Date	December 21, 2016
Days to Decision	198 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF