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FDA 510(k)

Elefix V Paste for EEG & EMG

K-Number: K191975 · 2020-02-07

ApplicantNihon Kohden Corporation
Decision Date2020-02-07
Product CodeGYB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Elefix V Paste for EEG & EMG is the device name listed in this FDA 510(k) record. The listed applicant is Nihon Kohden Corporation. It received FDA 510(k) clearance on 2020-02-07 under 510(k) number K191975. The device is classified under product code GYB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Elefix V Paste for EEG & EMG?

Elefix V Paste for EEG & EMG is a medical device that received FDA 510(k) clearance on 2020-02-07. The listed applicant is Nihon Kohden Corporation. The 510(k) number is K191975.

When did Elefix V Paste for EEG & EMG receive FDA 510(k) clearance?

Elefix V Paste for EEG & EMG received FDA 510(k) clearance on 2020-02-07, under 510(k) number K191975.

Who is the listed applicant for Elefix V Paste for EEG & EMG?

The FDA 510(k) record lists Nihon Kohden Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Elefix V Paste for EEG & EMG?

The FDA product code for Elefix V Paste for EEG & EMG is GYB.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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