Duns Number:690635461
Device Description: The NIDEK Chart Projector CP-770 is a test chart presenting device which can achieve refra The NIDEK Chart Projector CP-770 is a test chart presenting device which can achieve refraction distance from 2.9 m to 6.1 m. The device is controlled by a wireless remote control or a control box on the refractor (RT).The CP-770 features the following:• Equipped with 33 types of charts (27 types for Type UK) including various kinds of binocular charts• Program function that allows chart presentation with the touch of a button• Versatile masking function that can even offer the display of even a single character• Chart brightness adjustability to the installation conditions• Switchable function between display and non-display of visual acuity of the chart• A long-life LED for the illumination light source
Catalog Number
-
Brand Name
CHART PROJECTOR
Version/Model Number
CP-770
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
HOX
Product Code Name
Chart, Visual Acuity
Public Device Record Key
f41bb339-3ee6-4f6d-aeb1-2f4891e7ab64
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 10, 2016
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 |