Duns Number:692281073
Device Description: The Kowa KT-800 is indicated for measuring intraocular pressure without contacting the eye The Kowa KT-800 is indicated for measuring intraocular pressure without contacting the eye to aid in the screening and diagnosis of glaucoma.
Catalog Number
-
Brand Name
KOWA KT-800
Version/Model Number
TO8K
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
K053444
Product Code
HKX
Product Code Name
Tonometer, Ac-Powered
Public Device Record Key
eee1d92a-defe-48cc-881b-e9c889cc3db8
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 |