Duns Number:078505297
Device Description: Non-invasive, cutaneous electrode for use with recording and monitoring equipment of Elect Non-invasive, cutaneous electrode for use with recording and monitoring equipment of Electromyography (EMG).
Catalog Number
-
Brand Name
Dome Electrodes
Version/Model Number
1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
K190416,K190416
Product Code
GXY
Product Code Name
Electrode, Cutaneous
Public Device Record Key
65fa07bc-7599-4502-b95d-5d08c249eff3
Public Version Date
April 23, 2019
Public Version Number
1
DI Record Publish Date
April 15, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |