Duns Number:671280238
Device Description: Fiberlink transmitter is part of NordicNeuroLab’s fMRI System.Fiberlink transmitter conver Fiberlink transmitter is part of NordicNeuroLab’s fMRI System.Fiberlink transmitter converts audio and video signals into an optical signal for transmission.Fiberlink transmitter is used togheter with NordicNeuroLab’s Visual System and Audio System.
Catalog Number
-
Brand Name
Fiberlink transmitter
Version/Model Number
FLT 2.1
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K092253
Product Code
LNH
Product Code Name
System, Nuclear Magnetic Resonance Imaging
Public Device Record Key
538c33d6-9f16-4fe9-bac7-ce7203b8dd57
Public Version Date
June 02, 2020
Public Version Number
5
DI Record Publish Date
September 24, 2016
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. | 24 |