Duns Number:029957656
Device Description: Research model; optional 40 input EEG amplifier for direct recording of EEG and other phys Research model; optional 40 input EEG amplifier for direct recording of EEG and other physiological signals from the patient.
Catalog Number
-
Brand Name
Component Neuromonitoring System
Version/Model Number
CNS-EEG-310
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
K080217
Product Code
GWQ
Product Code Name
Full-Montage Standard Electroencephalograph
Public Device Record Key
b5ee8fcb-d844-4c07-a492-64bba2ff1a1f
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 21, 2017
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 |