Duns Number:079747524
Device Description: ECG Management System is a software only EGG management database that stores, displays, an ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data
Catalog Number
-
Brand Name
Epiphany Cardio Server
Version/Model Number
5.1.0
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"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K052883
Product Code
DQK
Product Code Name
Computer, Diagnostic, Programmable
Public Device Record Key
7cf0d760-10f5-494d-8082-24e18b7b179b
Public Version Date
February 28, 2019
Public Version Number
4
DI Record Publish Date
September 09, 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. | 7 |