Duns Number:690635461
Device Description: The Nidek CHART PROJECTOR CP-9 is a chart presenting device that can achieve refraction at The Nidek CHART PROJECTOR CP-9 is a chart presenting device that can achieve refraction at a distance of 2.9 m to 6.1 m (standard 5 m).The main unit is operated by a wireless remote control or the control box on a motorized refractor (RT).
Catalog Number
-
Brand Name
CHART PROJECTOR
Version/Model Number
CP-9
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
3339a373-b5cb-4cd3-9342-1aaeca221a4f
Public Version Date
October 11, 2021
Public Version Number
1
DI Record Publish Date
October 01, 2021
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 | 39 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 73 |
| 3 | A medical device with high risk that requires premarket approval | 5 |