eVox System

GUDID 00867606000304

The eVox System is intended for the acquisition, display, and storage, of electrical activity of a patient’s brain including electroencephalograph (EEG) and event-related potentials (ERP) obtained by placing two or more electrodes on the head to aid in diagnosis The medical system includes the “eVox System” amplifier device, accessories, and a computer (laptop computer or tablet device with internal battery and power cord). The hardware and ancillary components used in conjunction with the eVox System include an EEG cap, the eVox Amplifier, a charging kit (that consists of a USB cable, clip kit, and wall adapter), a Subject Response Device and a Base Station laptop computer. The software on the Base Station laptop computer is intended for device functioning

EVOKE NEUROSCIENCE, INC.

Electroencephalograph
Primary Device ID00867606000304
NIH Device Record Key6367d582-1be3-45de-973c-4541d717bd01
Commercial Distribution StatusIn Commercial Distribution
Brand NameeVox System
Version Model NumberEVO-002-400-000
Company DUNS962456898
Company NameEVOKE NEUROSCIENCE, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone9172616096
Emailinfo@evokeneuroscience.com
Phone9172616096
Emailinfo@evokeneuroscience.com
Phone9172616096
Emailinfo@evokeneuroscience.com
Phone9172616096
Emailinfo@evokeneuroscience.com
Phone9172616096
Emailinfo@evokeneuroscience.com
Phone9172616096
Emailinfo@evokeneuroscience.com
Phone9172616096
Emailinfo@evokeneuroscience.com
Phone9172616096
Emailinfo@evokeneuroscience.com
Phone9172616096
Emailinfo@evokeneuroscience.com
Phone9172616096
Emailinfo@evokeneuroscience.com
Phone9172616096
Emailinfo@evokeneuroscience.com
Phone9172616096
Emailinfo@evokeneuroscience.com
Phone9172616096
Emailinfo@evokeneuroscience.com
Phone9172616096
Emailinfo@evokeneuroscience.com
Phone9172616096
Emailinfo@evokeneuroscience.com
Phone9172616096
Emailinfo@evokeneuroscience.com
Phone9172616096
Emailinfo@evokeneuroscience.com
Phone9172616096
Emailinfo@evokeneuroscience.com
Phone9172616096
Emailinfo@evokeneuroscience.com
Phone9172616096
Emailinfo@evokeneuroscience.com
Phone9172616096
Emailinfo@evokeneuroscience.com
Phone9172616096
Emailinfo@evokeneuroscience.com
Phone9172616096
Emailinfo@evokeneuroscience.com
Phone9172616096
Emailinfo@evokeneuroscience.com
Phone9172616096
Emailinfo@evokeneuroscience.com
Phone9172616096
Emailinfo@evokeneuroscience.com
Phone9172616096
Emailinfo@evokeneuroscience.com
Phone9172616096
Emailinfo@evokeneuroscience.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100867606000304 [Primary]

FDA Product Code

HCCDevice, Biofeedback

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-22
Device Publish Date2021-10-14

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