Duns Number:024168209
Device Description: Persyst 12 is a quantitative EEG trending, spike and seizure detection software. Persyst 1 Persyst 12 is a quantitative EEG trending, spike and seizure detection software. Persyst 12 is used for both monitoring and trending of EEG recordings during acquisition and reviewing of processed recordings.
Catalog Number
-
Brand Name
Persyst 12 EEG Review and Analysis Software
Version/Model Number
P12
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
K133793
Product Code
OLT
Product Code Name
Non-Normalizing Quantitative Electroencephalograph Software
Public Device Record Key
3e8dbe16-d2a2-4239-a5be-43557c5f359c
Public Version Date
July 12, 2019
Public Version Number
4
DI Record Publish Date
September 01, 2016
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 |