Duns Number:300916041
Device Description: The g.HIamp is intended to be used for measuring, recording and analysing of electrical ac The g.HIamp is intended to be used for measuring, recording and analysing of electrical activityof the brain and/or through the attachment of multiple electrodes at various locations to aid inmonitoring and diagnosis as routinely found in clinical settings for EEG. It captures the data,converts it into digital form and passes it on to a host computer running appropriate software. Thedevice can be used for adults, children, infants and animals.
Catalog Number
7003
Brand Name
g.HIamp
Version/Model Number
256-Channel Amplifier
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 31, 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
K123255
Product Code
GWL
Product Code Name
Amplifier, Physiological Signal
Public Device Record Key
8830cf58-3565-4565-9fe5-d238a9933d6f
Public Version Date
January 31, 2019
Public Version Number
5
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 |