K-number	K191975
Device name	Elefix V Paste for EEG & EMG
Applicant	Nihon Kohden Corporation
Product code	GYB
Device class	Class II
Decision date	Feb 7, 2020
Decision	Substantially Equivalent
Regulation	882.1275

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Source

View the full FDA submission: accessdata.fda.gov

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Elefix V Paste for EEG & EMG

Everything you need for a 510(k) submission. Nothing you don't.