Duns Number:016038297
Device Description: The Insight Infrared Video Goggles are designed to be used by clinicians to visualize and The Insight Infrared Video Goggles are designed to be used by clinicians to visualize and record patient eye movements. The goggles will be placed on the patient’s head with the cameras in front of the patient’s eyes. The infrared cameras transmit video of the eye movements to a compatible computer screen for display. The computer uses an off-the-shelf video software Open Broadcaster Software (OBS) to allow viewing and recording of the cameras.
Catalog Number
-
Brand Name
Vestibular First
Version/Model Number
Insight Infrared Video Goggles
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K203082,K203082
Product Code
GWN
Product Code Name
Nystagmograph
Public Device Record Key
d833038b-1e92-4942-b21d-67cc61c7fc23
Public Version Date
November 25, 2020
Public Version Number
1
DI Record Publish Date
November 17, 2020
Package DI Number
10860002280704
Quantity per Package
6
Contains DI Package
00860002280707
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |