Duns Number:051244569
Device Description: LCD touch screen recording system with HDMI loop through.Software version 1.7.25
Catalog Number
-
Brand Name
Evolution4K
Version/Model Number
Evo4K130
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 13, 2021
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
-
Product Code
LMB
Product Code Name
Device, Digital Image Storage, Radiological
Public Device Record Key
4543c259-e08a-4249-b7b6-6abb89a85abc
Public Version Date
April 14, 2021
Public Version Number
2
DI Record Publish Date
June 30, 2020
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 | 86 |