Duns Number:291642445
Device Description: VICON Vero is a system for motion analysis, intended for the recording and analysis of hum
Catalog Number
VICON VERO SYSTEM
Brand Name
VICON
Version/Model Number
VERO SYSTEM
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)
-
Device labeled as "Not made with natural rubber latex"
Yes
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
K811172
Product Code
LXJ
Product Code Name
System, Optical Position/Movement Recording
Public Device Record Key
3a73d3d6-5837-4863-9885-2d1a709488bc
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
April 18, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |