DAEHAN Disposable CUP Electrodes— 510(k) K180232

Name: FDA 510(k) clearance K180232
Creator: U.S. Food and Drug Administration
Published: 2019-04-03

Substantially Equivalent

Daehan Medical Systems Co., Ltd.

FDA 510(k) clearance K180232 for DAEHAN Disposable CUP Electrodes, Substantially Equivalent on 2019-04-03. Applicant: Daehan Medical Systems Co., Ltd.. Device class: 2.

Clearance details

Applicant: Daehan Medical Systems Co., Ltd.
Product code: Code GXY
Device class: Class 2
Regulation: 21 CFR 882.1320
Advisory panel: Neurology
Date received: 2018-01-29
Decision date: 2019-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Siheung-City, KR

Download summary PDF View on FDA.gov ↗

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