Duns Number:654386890
Device Description: CM-1900C LCD Chart monitorNew design, narrow bezel, ultra thin.23 inch LCD screen, suitabl CM-1900C LCD Chart monitorNew design, narrow bezel, ultra thin.23 inch LCD screen, suitable for all kinds of environmentIndividua red/green l test, support blue-tooth and IR connectionUnique astigmatism axis chart and fast visual acuity check chartChart size adjustable according to test distance
Catalog Number
-
Brand Name
LCD CHART MONITOR
Version/Model Number
CM-1900C
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
18a18ae6-44d2-4d95-8106-6726242070b7
Public Version Date
December 10, 2019
Public Version Number
1
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 |