Elefix V Paste for EEG & EMG— 510(k) K191975

Name: FDA 510(k) clearance K191975
Creator: U.S. Food and Drug Administration
Published: 2020-02-07

Substantially Equivalent

Nihon Kohden Corporation

FDA 510(k) clearance K191975 for Elefix V Paste for EEG & EMG, Substantially Equivalent on 2020-02-07. Applicant: Nihon Kohden Corporation. Device class: 2.

Clearance details

Applicant: Nihon Kohden Corporation
Product code: Code GYB
Device class: Class 2
Regulation: 21 CFR 882.1275
Advisory panel: Neurology
Date received: 2019-07-24
Decision date: 2020-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tokyo, JP

Download summary PDF View on FDA.gov ↗

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