Elefix V Paste For EEG & EMG

Media, Electroconductive

Nihon Kohden Corporation

The following data is part of a premarket notification filed by Nihon Kohden Corporation with the FDA for Elefix V Paste For Eeg & Emg.

Pre-market Notification Details

Device IDK191975
510k NumberK191975
Device Name:Elefix V Paste For EEG & EMG
ClassificationMedia, Electroconductive
Applicant Nihon Kohden Corporation 1-31-4 Nishiochiai, Shinjuku-ku Tokyo,  JP 161-8560
ContactSandra Gadeyne
CorrespondentNatalie Kennel
NJK & Associates, Inc. 13721 Via Tres Vista San Diego,  CA  92129
Product CodeGYB  
CFR Regulation Number882.1275 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyNeurology
510k Review PanelNeurology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-24
Decision Date2020-02-07

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