Duns Number:545824560
Device Description: It is a manual device intended for measurement of intraocular pressure by applanation (app It is a manual device intended for measurement of intraocular pressure by applanation (applying a small flat disk to the cornea) to aid the diagnosis of glaucoma
Catalog Number
-
Brand Name
Applanation Tonometer
Version/Model Number
SK-R
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K191314,K191314,K191314,K191314,K191314
Product Code
HKY
Product Code Name
Tonometer, Manual
Public Device Record Key
5d25bd96-426b-4022-954b-ea27716bea9a
Public Version Date
July 10, 2020
Public Version Number
1
DI Record Publish Date
July 02, 2020
Package DI Number
26973211070491
Quantity per Package
2
Contains DI Package
06973211070671
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20 |