Duns Number:300916041
Device Description: The g.USBamp is inteded to measuring, recording and analysis of electrical activity of the The g.USBamp is inteded to measuring, recording and analysis of electrical activity of the brain (EEG) and/or through the attachment of multiple electrodes at various locations to aid in monitoring and diagnosis as routinely found in clinical settings for the EEG.
Catalog Number
0216
Brand Name
g.USBamp
Version/Model Number
USB Biosignal Amplifier
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 08, 2019
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
K060803
Product Code
GWL
Product Code Name
Amplifier, Physiological Signal
Public Device Record Key
8a212b19-e965-47bf-9ae2-c58481dca095
Public Version Date
February 21, 2020
Public Version Number
4
DI Record Publish Date
April 12, 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 |