Duns Number:265828238
Device Description: Neuronaute Head Module is intended to acquire, display, store, and archive EEG signals fro Neuronaute Head Module is intended to acquire, display, store, and archive EEG signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations in order to assist in the diagnosis of neurological disorders by a physician.
Catalog Number
1001-10004-US
Brand Name
Neuronaute 1.2 - Head module
Version/Model Number
1.2
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K202334
Product Code
GWQ
Product Code Name
Full-Montage Standard Electroencephalograph
Public Device Record Key
44a7aaa0-1966-461f-b37c-d34494979269
Public Version Date
February 23, 2021
Public Version Number
1
DI Record Publish Date
February 15, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 22 |