FDA 510(k)

Elefix V Paste for EEG & EMG

K-Number: K191975 · 2020-02-07

Decision Date2020-02-07

Product CodeGYB

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Elefix V Paste for EEG & EMG is a medical device manufactured by Nihon Kohden Corporation. It received FDA 510(k) clearance on 2020-02-07 under approval 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. It is manufactured by Nihon Kohden Corporation. The 510(k) number is K191975.

When was Elefix V Paste for EEG & EMG approved by the FDA?

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

What company makes Elefix V Paste for EEG & EMG?

Elefix V Paste for EEG & EMG is manufactured by Nihon Kohden Corporation.

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.

Other Devices by Nihon Kohden Corporation

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Official Source

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