eVox System

Primary DI
00867606000304
Brand
eVox System
Company
Firefly Neuroscience, Inc.
Model
EVO-002-400-000
Device description
The eVox System is intended for the acquisition, display, and storage, of electrical activityof 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 diagnosisThe medical system includes the “eVox System” amplifier device, accessories, and acomputer (laptop computer or tablet device with internal battery and power cord).The hardware and ancillary components used in conjunction with the eVox System includean EEG cap, the eVox Amplifier, a charging kit (that consists of a USB cable, clip kit, andwall adapter), a Subject Response Device and a Base Station laptop computer. Thesoftware on the Base Station laptop computer is intended for device functioning
Published
2021-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWJStimulator, Auditory, Evoked Response
GWQFull-Montage Standard Electroencephalograph
HCCDevice, Biofeedback

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWJStimulator, Auditory, Evoked ResponseNeurology2
GWQFull-Montage Standard ElectroencephalographNeurology2
HCCDevice, BiofeedbackNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00867606000304PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00867606000304008676060003048676060003040867606000304

GMDN Terms#

Term, Definition table
TermDefinition
ElectroencephalographA line-powered device used to record the variations of the electrical potential caused by the electrical activity of the brain, usually detected at the patient's scalp. Leads affixed to the scalp and ear lobes transmit the electric signals to the recorder, which in turn reproduces their characteristics in an electroencephalogram (EEG). They are used to study a variety of neurological conditions, evaluate psychiatric disorders and assist in localizing tumours or lesions on or near the surface of the brain.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9172616096info@evokeneuroscience.com

Regulatory Flags#

DUNS number
016700718
Device count
1

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