Duns Number:654386890
Device Description: The new Intellectual interaction modeThe new CV-7800 auto phoropter has made great improve The new Intellectual interaction modeThe new CV-7800 auto phoropter has made great improvement in human and machine interaction compared to last generation. It supports both tablet and control panel control, making the operation more flexible for more outstanding refraction.More efficient and faster control and operation1.Quieter and all-roundThanks to the brand new mechnicial design and imported motors, the Tianle CV-7800 auto phoropter not only make less noise for lens switch, but also provide more outstanding refraction result, providing our user with less annoying noise and more plsasant using experience.2.Excellent apperance & performanceWith a new look dsiplays sense of technology and faster lens switch speed and longer working lfie, the new CV-7800 is refined both internally and externally.3.Customized refraction processThe strong intellectual interaction mode supports uyser to customize refraction process according to their own habit. Multiple control method makes all the operation more intelligent and efficient.
Catalog Number
-
Brand Name
Computerized vision tester
Version/Model Number
CV-7800
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
-
Product Code
HIT
Product Code Name
Tester, Color Vision
Public Device Record Key
53deb296-a702-4f4f-bc2b-189960b3032b
Public Version Date
December 21, 2020
Public Version Number
2
DI Record Publish Date
August 20, 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 | 15 |