Duns Number:370173410
Device Description: The videonystagmoscope transcribes the image of the patient's eye on a computer screen. Th The videonystagmoscope transcribes the image of the patient's eye on a computer screen. The VIDEOSTAR can thus assess the reactions of the patient viewing his nystagmus during testing positions, caloric, rotary or due to any other stimulus. The camera can be placed in front of the patient's right or left eye. The camera is fixed on a mask, fitting the line of the patient's face in order to occult completely from the outside light. The second eye view is either closed by an eyepiece or let free, which leaves it a free view.TECHNICAL SPECIFICATION:USB 2.0 connection30 frames/sResolution: 640 x 480 pixelsCable of 5 metersCompatible Windows Seven/8 - 32 or 64 bits
Catalog Number
22090
Brand Name
Instrumentation Difra
Version/Model Number
VIDEOSTAR
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
-
Product Code
HJJ
Product Code Name
Lens, Fresnel, Flexible, Diagnostic
Public Device Record Key
b5b5522f-9ca8-4c3c-bb9a-2d2e870d310f
Public Version Date
October 18, 2018
Public Version Number
1
DI Record Publish Date
September 17, 2018
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 |