DMS Disposable Subdermal Needle Electrodes— 510(k) K161566

Name: FDA 510(k) clearance K161566
Creator: U.S. Food and Drug Administration
Published: 2016-12-21

Substantially Equivalent

Daehan Medical Systems Co., Ltd.

FDA 510(k) clearance K161566 for DMS Disposable Subdermal Needle Electrodes, Substantially Equivalent on 2016-12-21. Applicant: Daehan Medical Systems Co., Ltd.. Device class: 2.

Clearance details

Applicant: Daehan Medical Systems Co., Ltd.
Product code: Code GXZ
Device class: Class 2
Regulation: 21 CFR 882.1350
Advisory panel: Neurology
Date received: 2016-06-06
Decision date: 2016-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Siheung-City, KR

Download summary PDF View on FDA.gov ↗

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