Duns Number:933200842
Device Description: Pegasus is the software component of the ATLAS Neurophysiology System that interfaces with Pegasus is the software component of the ATLAS Neurophysiology System that interfaces with the amplifier. It is used to display, store and archive EEG signals and allow user-only annotation and marking. Pegasus does not analyze EEG or automatically detect events.
Catalog Number
Pegasus
Brand Name
Pegasus
Version/Model Number
2.1.0
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
K110967
Product Code
OMC
Product Code Name
Reduced- Montage Standard Electroencephalograph
Public Device Record Key
09e4bf7a-64d5-4fe4-8586-9cff95330d1a
Public Version Date
September 19, 2018
Public Version Number
4
DI Record Publish Date
August 31, 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. | 50 |