Duns Number:557821283
Device Description: PROVUE is an automatic visual acuity system, stand-alone type, which displays broad range PROVUE is an automatic visual acuity system, stand-alone type, which displays broad range of charts, based on LCD panel, including red /green for the eye optometry. The chart rotation for PROVUE can be performed by wireless remote control or by wired external devices such as the control box of Digital Phoropter. Unlike existing chart projector, PROVUE is able to provide wider range of charts (more than 100 kinds of general and special charts) on LCD panel and the product can be adjusted at the level of the patients for precise examination.
Catalog Number
PROVUE
Brand Name
LCD ACUITY DEVICE
Version/Model Number
PROVUE
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
-
Product Code
HOX
Product Code Name
Chart, Visual Acuity
Public Device Record Key
7263aeda-6dc9-401e-89db-d7a6ab8c4853
Public Version Date
September 24, 2020
Public Version Number
1
DI Record Publish Date
September 16, 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 | 1 |