Duns Number:300916041
Device Description: The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and tr The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
Catalog Number
5211PRO
Brand Name
g.Nautilus PRO
Version/Model Number
16-Channel-mB Sahara
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K171669
Product Code
GWL
Product Code Name
Amplifier, Physiological Signal
Public Device Record Key
16ab0ebf-7a8e-4824-8ca6-fec5f43619c6
Public Version Date
December 02, 2020
Public Version Number
4
DI Record Publish Date
November 23, 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. | 28 |