FDA 510(k)

eVox System

K-Number: K171781 · 2017-12-13

Decision Date2017-12-13

Product CodeGWQ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

eVox System is the device name listed in this FDA 510(k) record. The listed applicant is Evoke Neuroscience, Inc.. It received FDA 510(k) clearance on 2017-12-13 under 510(k) 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. The listed applicant is Evoke Neuroscience, Inc.. The 510(k) number is K171781.

When did eVox System receive FDA 510(k) clearance?

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

Who is the listed applicant for eVox System?

The FDA 510(k) record lists Evoke Neuroscience, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for eVox System?

The FDA product code for eVox System is GWQ.

Related Devices (Code: GWQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261604Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)Neuroelectrics Barcelona S.L.U.K260455New Wave SystemZeto, Inc.K233403Flexset SystemZeto, Inc.K231366Neuronaute PlusBioserenity Sas K221959Q21Neurofield, Inc.K231457SPARK ScanSpark Neuro, Inc.

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.