Duns Number:692281073
Device Description: KOWA VK-2s is indicated for acquiring, displaying and storing image data from KOWA's mydri KOWA VK-2s is indicated for acquiring, displaying and storing image data from KOWA's mydriatic and non-mydriatic ophthalmic cameras.
Catalog Number
-
Brand Name
KOWA VK-2s
Version/Model Number
VK28K
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 10, 2019
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
K190056
Product Code
NFJ
Product Code Name
System, Image Management, Ophthalmic
Public Device Record Key
294ad772-6f30-4db6-b112-cd600f07a7bf
Public Version Date
June 18, 2019
Public Version Number
1
DI Record Publish Date
June 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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |