Duns Number:654386890
Device Description: This instrument is used to measure the spherical refractive-power, cylindrical refractive This instrument is used to measure the spherical refractive-power, cylindrical refractive power, the direction of astigmatic axis.RM-9000 Measuring fuction only has refractive measurement.RM-9000 Auto refractometerAdopts the ARM processor and image processing technology in China—faster system and clearer imageMature technique from Japan. Humanized auto mist test process: will reduce errors caused by human eye adjustments—more accurate measure resultsIntegral pressing and CNC machining for the optical rack: ensure the measurement consistency and accuracy—more stable system5.7" LCD color screen provides more comfortable interfaceSupports the data transmission with auto phoropter, improving the work efficiencyAuto PD measurementOne-key lock function, enables to lock the moving head fasterNovel design and ergonomic structure can give the customer a sense of beauty and comfortable operation.
Catalog Number
-
Brand Name
AUTO REF/KERATOMETER
Version/Model Number
RM-9000
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"
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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
HKO
Product Code Name
Refractometer, Ophthalmic
Public Device Record Key
618c4c33-b392-40ad-9918-635eae800d14
Public Version Date
December 21, 2020
Public Version Number
3
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 |