FDA 510(k)

WAVi Headset and WAVi eSoc Single Use Electrode Contacts

K-Number: K162460 · 2017-04-28

Decision Date2017-04-28

Product CodeGXY

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

WAVi Headset and WAVi eSoc Single Use Electrode Contacts is a medical device manufactured by Wavi Co.. It received FDA 510(k) clearance on 2017-04-28 under approval number K162460. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WAVi Headset and WAVi eSoc Single Use Electrode Contacts?

WAVi Headset and WAVi eSoc Single Use Electrode Contacts is a medical device that received FDA 510(k) clearance on 2017-04-28. It is manufactured by Wavi Co.. The 510(k) number is K162460.

When was WAVi Headset and WAVi eSoc Single Use Electrode Contacts approved by the FDA?

WAVi Headset and WAVi eSoc Single Use Electrode Contacts received FDA 510(k) clearance on 2017-04-28, under approval number K162460.

What company makes WAVi Headset and WAVi eSoc Single Use Electrode Contacts?

WAVi Headset and WAVi eSoc Single Use Electrode Contacts is manufactured by Wavi Co..

What is the FDA product code for WAVi Headset and WAVi eSoc Single Use Electrode Contacts?

The FDA product code for WAVi Headset and WAVi eSoc Single Use Electrode Contacts is GXY.

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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.