Duns Number:024168209
Device Description: This is an application intended to be used by neurologists who are monitoring or reviewing This is an application intended to be used by neurologists who are monitoring or reviewing EEGs. It is part of a larger system provided by Persyst.
Catalog Number
-
Brand Name
Persyst Mobile App
Version/Model Number
App for Web
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
K171184
Product Code
OLT
Product Code Name
Non-Normalizing Quantitative Electroencephalograph Software
Public Device Record Key
47d51dff-a409-4e89-997f-936ad663a803
Public Version Date
July 12, 2019
Public Version Number
2
DI Record Publish Date
April 08, 2019
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. | 5 |