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FDA 510(k)

eVox System

K-Number: K171781 · 2017-12-13

ApplicantEvoke Neuroscience, Inc.
Decision Date2017-12-13
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

eVox System is a medical device manufactured by Evoke Neuroscience, Inc.. It received FDA 510(k) clearance on 2017-12-13 under approval number K171781. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the eVox System?

eVox System is a medical device that received FDA 510(k) clearance on 2017-12-13. It is manufactured by Evoke Neuroscience, Inc.. The 510(k) number is K171781.

When was eVox System approved by the FDA?

eVox System received FDA 510(k) clearance on 2017-12-13, under approval number K171781.

What company makes eVox System?

eVox System is manufactured by Evoke Neuroscience, Inc..

What is the FDA product code for eVox System?

The FDA product code for eVox System is GWQ.

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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.

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