Duns Number:688154202
Device Description: The Auto Ref/Keratometer is intended to be used to measure the refractive power of the eye
Catalog Number
HRK-8000A
Brand Name
Auto Ref-Keratometer HRK-8000A
Version/Model Number
HRK-8000A
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)
-
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
8a2a7d67-da43-421b-b373-605912efd7bf
Public Version Date
May 20, 2019
Public Version Number
1
DI Record Publish Date
May 10, 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 | 18 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |