Duns Number:029957656
Device Description: Software for use in the review, annotation and analysis of patient data collected using ex Software for use in the review, annotation and analysis of patient data collected using external physiological monitors.
Catalog Number
-
Brand Name
CNS Envision
Version/Model Number
VIS-100
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"
-
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
K192572
Product Code
OLT
Product Code Name
Non-Normalizing Quantitative Electroencephalograph Software
Public Device Record Key
709801aa-d45e-43ff-ba15-8f3da4b6ca4f
Public Version Date
January 07, 2022
Public Version Number
2
DI Record Publish Date
October 28, 2020
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. | 22 |