Duns Number:500793540
Device Description: The Stratus EEG Acquisition is a medical device that is is intended for acquisition and re The Stratus EEG Acquisition is a medical device that is is intended for acquisition and review of EEG and other physiological data as well video synchronized to the EEG. The EEG is presented in a conventional way and conventional signal processing is applied such as re-montaging and band pass filtering. The system is also capable of presenting digital video synchronized to the EEG if this is available. Some advanced analysis methods are provided as an aid: FFT analysis and Artifact Removal.The software is designed using service oriented architecture enabling the possibility of reviewing data over WAN without the use of additional remote desktop software solutions.
Catalog Number
-
Brand Name
Stratus EEG
Version/Model Number
Acquisition
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"
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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
K143487,K143487
Product Code
GWQ
Product Code Name
Full-Montage Standard Electroencephalograph
Public Device Record Key
a90a140d-9f2f-4176-9b9d-2bd08459ebc1
Public Version Date
February 05, 2021
Public Version Number
1
DI Record Publish Date
January 28, 2021
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. | 14 |