Duns Number:305415202
Device Description: The ECGenius System is a computerized electrophysiology measurement system designed for b The ECGenius System is a computerized electrophysiology measurement system designed for both regular and experimental EP studies.The ECGenius System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record clinical data obtained during electrophysiological studies and related procedures. The system is compatible with a 3rd-party stimulator, intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.
Catalog Number
CVT-0069 R2.0 ECGenius System
Brand Name
ECGenius System
Version/Model Number
CVT-0069 R2.0
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
K220306
Product Code
DQK
Product Code Name
Computer, Diagnostic, Programmable
Public Device Record Key
046a4c61-4b4f-44e1-8c12-de332ae46393
Public Version Date
June 23, 2022
Public Version Number
1
DI Record Publish Date
June 15, 2022
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 |