Duns Number:654386890
Device Description: The space saving chart CM-2200 achieves the refraction distance of 5 m within an installat The space saving chart CM-2200 achieves the refraction distance of 5 m within an installation distance of 0.8 m. The CM-2200 is a chart presenting device. The built-in optical system presents charts toward the back of the chart window. The VA (visual acuity) charts are composed of the four types of letters, Tumbling E, number, and children.
Catalog Number
-
Brand Name
LCD Chart monitor
Version/Model Number
CM-2200
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
e20e2867-a8f9-4c89-b571-7a62ddd3f1c3
Public Version Date
August 09, 2021
Public Version Number
1
DI Record Publish Date
July 30, 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 | 15 |