Duns Number:532013976
Device Description: An instrument designed to measure electrical potentials on the body surface to generate a An instrument designed to measure electrical potentials on the body surface to generate a record of the electrical currents associated with heart muscle activity. [i.e., an electrocardiogram (ECG) for the assessment of cardiac physiology. It records electrical signals from 12 leads simultaneously, thus simplifying and facilitating the interpretation of the record by enabling the comparison of the 12-lead recording of the same heartbeat. It records data in electronic form for later analysis by software or a healthcare professional.
Catalog Number
5-045-00
Brand Name
Commwell
Version/Model Number
ES-ECG System
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
K083677
Product Code
DRX
Product Code Name
Electrode, Electrocardiograph
Public Device Record Key
ea5dcbf1-cc31-4e76-b06f-d69636d31fcd
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 25, 2017
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. | 4 |