Duns Number:654386890
Device Description: The product is used for subjectively checking eye sight ,and provide diagnosis for ophtha The product is used for subjectively checking eye sight ,and provide diagnosis for ophthalmologist It belongs to non-invasive device,and it may be contacted on patient’s face for short time about several minutes.Just a single dial enabling every operation.Ergonomic switch sheet layout.Easy touch buttons for blind operation.The contents of chart display to be confirmed even in examination in the dark room.The CV-7600 is a computerized autophoropter,including a phoropter head, a controller and a power adapter.
Catalog Number
-
Brand Name
COMPUTERIZED VISION TESTER
Version/Model Number
CV-7600
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
dcf91646-712b-4ba4-8790-12b8277958e8
Public Version Date
December 21, 2020
Public Version Number
2
DI Record Publish Date
December 02, 2019
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 |