Duns Number:933200842
Device Description: The ADPT-NKSS-Y-A is an adapter cable that allows signals from an electrode interface by N The ADPT-NKSS-Y-A is an adapter cable that allows signals from an electrode interface by Nihon Kohden Corporation to be recorded by both the JE-120A Amplifier by Nihon Kohden Corporation and the JE-212A Amplifier by Nihon Kohden Corporation.
Catalog Number
31-0602-0007
Brand Name
ADPT-NKSS-Y-A Adapter Cable
Version/Model Number
ADPT-NKSS-Y-A Adapter Cable
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 27, 2020
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
7573dbae-9c72-4322-903b-00f617db016a
Public Version Date
February 28, 2020
Public Version Number
3
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 |