Duns Number:692281073
Device Description: KOWA FM-600 is an instrument to measure the protein level contained in aqueous humor of th KOWA FM-600 is an instrument to measure the protein level contained in aqueous humor of the anterior chamber of human eye.
Catalog Number
-
Brand Name
KOWA FM-600
Version/Model Number
LSS50BK
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
K091039
Product Code
MYC
Product Code Name
Ophthalmoscope,Laser,Scanning
Public Device Record Key
cb1ee304-13ff-4c43-9105-03c9ade03685
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 16, 2016
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 |