Duns Number:654386890
Device Description: KR-9800 Auto ref/keratometer has the functions of both refractometer and keratometer.This KR-9800 Auto ref/keratometer has the functions of both refractometer and keratometer.This instrument is used to measure the spherical refractive-power, cylindrical refractive power, the direction of astigmatic axis.
Catalog Number
-
Brand Name
AUTO REF/KERATOMETER
Version/Model Number
KR-9800
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
HKO
Product Code Name
Refractometer, Ophthalmic
Public Device Record Key
1613ca92-07af-4ab1-bd70-68866d439758
Public Version Date
June 30, 2021
Public Version Number
1
DI Record Publish Date
June 22, 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 |