Duns Number:692281073
Device Description: KOWA nonmyd a-DIII, fundus camera, is intended for use with retinal image capturing withou KOWA nonmyd a-DIII, fundus camera, is intended for use with retinal image capturing without mydriatic. The retinal image can be stored to an image filing drive through serial interface.
Catalog Number
-
Brand Name
KOWA nonmyd a-DIII
Version/Model Number
K9L58K
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
K082767
Product Code
HKI
Product Code Name
Camera, Ophthalmic, Ac-Powered
Public Device Record Key
903a6991-7b9e-41ed-a21d-4edd2505845b
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 23, 2018
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 |