Duns Number:962456898
Device Description: The eVox System is intended for the acquisition, display, and storage, of electrical activ 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
Catalog Number
-
Brand Name
eVox System
Version/Model Number
EVO-002-400-000
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
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Device labeled as "Not made with natural rubber latex"
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For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GWJ
Product Code Name
Stimulator, Auditory, Evoked Response
Public Device Record Key
6367d582-1be3-45de-973c-4541d717bd01
Public Version Date
October 22, 2021
Public Version Number
1
DI Record Publish Date
October 14, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |