Duns Number:370173410
Device Description: The videonystagmography performed by a camera and infra red light measures and records the
Catalog Number
22135
Brand Name
Intrumentation Difra
Version/Model Number
HeadStar
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K070670
Product Code
GWN
Product Code Name
Nystagmograph
Public Device Record Key
5ee02e8c-451d-493b-9b1b-629f82d0a0d9
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
May 19, 2017
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |