Duns Number:692281073
Device Description: KOWA AP-7000 is an automatic perimeter to perform perimetry examinations and to display an KOWA AP-7000 is an automatic perimeter to perform perimetry examinations and to display and output examination results.Static quantitative perimetry examinations and kinetic perimetry examinations are available.
Catalog Number
-
Brand Name
KOWA AP-7000
Version/Model Number
FT10K
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
HPT
Product Code Name
Perimeter, Automatic, Ac-Powered
Public Device Record Key
d00a06db-8137-490a-aaf8-c83984197800
Public Version Date
February 08, 2019
Public Version Number
1
DI Record Publish Date
January 08, 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 |