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
5.3
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)
-
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
e2f189cf-17f6-4d0a-988e-979320dee37e
Public Version Date
December 13, 2018
Public Version Number
1
DI Record Publish Date
November 12, 2018
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 |