Duns Number:126650253
Device Description: AC -powered non-contact tonometer intended to measure the intraocular pressure of the eye, AC -powered non-contact tonometer intended to measure the intraocular pressure of the eye, taking into consideration the biomechanical response of the cornea. An air puff is used to momentarily flatten a patient's cornea during the measurement.
Catalog Number
-
Brand Name
Reichert® 7CR Auto Tonometer
Version/Model Number
16060
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
K081756
Product Code
HKX
Product Code Name
Tonometer, Ac-Powered
Public Device Record Key
23467865-52b2-4777-b96e-7eb6a4453f53
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 22, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 22 |