Duns Number:016038297
Device Description: The Insight Infrared Video Goggles Pro are intended for viewing and recording eye movement The Insight Infrared Video Goggles Pro are intended for viewing and recording eye movements in support of identifying vestibular disorders in patients. The device is intended for use only by a trained healthcare professional in an appropriate healthcare setting. This device provides no diagnoses nor does it provide diagnostic recommendations. The target population is 12+ years of age.
Catalog Number
INSIGHT-VIDEO-GOGGLES-PRO
Brand Name
Vestibular First
Version/Model Number
Insight Infrared Video Goggles Pro
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
c7a4f58e-2113-453e-9a9f-6574b2f67218
Public Version Date
November 19, 2021
Public Version Number
1
DI Record Publish Date
November 11, 2021
Package DI Number
10860002280735
Quantity per Package
6
Contains DI Package
00860002280738
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 |