eVox System

FDA UDI

Class II (US FDA UDI)

by Evoke Neuroscience, Inc.

Identity

Trade Name: eVox System FDA UDI
Generic Name: Electroencephalograph FDA UDI
Device Name: 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 FDA UDI
Model / Reference: EVO-002-400-000 FDA UDI
Description: 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 FDA UDI

Identifiers

Primary DI / UDI-DI: 00867606000304 FDA UDI
FDA Product Code: HCC FDA UDI
GWQ FDA UDI
GWJ FDA UDI
GMDN Term: Electroencephalograph FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.5050 FDA UDI
882.1400 FDA UDI
882.1900 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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Single Use

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Implantable

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Contains Latex

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Prescription Use

Yes

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Over-the-Counter

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Convenience Kit

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Combination Product

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HCT/P

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Premarket Exempt

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Lot / Batch Number

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Serial Number

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Expiration Date

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Manufacturing Date

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Category: Electroencephalograph

eVox System by Evoke Neuroscience, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Zeto ONE Head Unit - Small — ZETO INC · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Evoke Neuroscience, Inc.

Sources (1)

FDA UDI 6367d582-1be3-45de-973c-4541d717bd01 34 fields · synced Jun 7, 2026