EVOKE NEUROSCIENCE, INC.

Address:1115 Broadway,New York City,NY,10010,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Device, Biofeedback (HCC) (1) Full-Montage Standard Electroencephalograph (GWQ) (1) Stimulator, Auditory, Evoked Response (GWJ) (1)

Premarket Exempt

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eVox System - 00867606000304 Catalog Number :

Device Description : The eVox System is intended for the acquisition, display, and storage, of electr 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

Device Class : 2

Duns Number: 962456898

Premarket Exempt : No

Product Code : HCC, GWQ, GWJ

Prescription Use : Yes

Device Count : 1

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