Duns Number:933200842
Device Description: The ADPT-NKSS-DRS-A is an adapter cable that allows signals from an electrode interface to The ADPT-NKSS-DRS-A is an adapter cable that allows signals from an electrode interface to be recorded by not only the ATLAS Neurophysiology System (K110967) by Neuralynx, Inc. but also the JE-120A Amplifier (K113117), by Nihon Kohden Corporation.
Catalog Number
31-0602-0002
Brand Name
ADPT-NKSS-DRS-A AdapterCable
Version/Model Number
ADPT-NKSS-DRS-A AdapterCable
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
-
Product Code
IKD
Product Code Name
Cable, Electrode
Public Device Record Key
0e43727f-c038-478b-9140-414f6f3b1c50
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 15, 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. | 50 |