Duns Number:688038491
Device Description: DAEHAN Disposable CUP Electrodes are intended for non-invasive use with recording and moni DAEHAN Disposable CUP Electrodes are intended for non-invasive use with recording and monitoring equipment, (active and reference), of Electromyography(EMG), Electroencephalograph (EEG) and Evoked potentials(EP).
Catalog Number
-
Brand Name
DAEHAN Disposable cup electrode
Version/Model Number
DCW 30C
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
Yes
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
K180232
Product Code
GXY
Product Code Name
Electrode, Cutaneous
Public Device Record Key
2f9f2855-99ef-4b0f-9e64-beef13dee8fe
Public Version Date
December 23, 2019
Public Version Number
1
DI Record Publish Date
December 13, 2019
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. | 1 |