Duns Number:543066376
Device Description: The projection perimeter is used to check the sensitivity of the human eye to light(visual The projection perimeter is used to check the sensitivity of the human eye to light(visual acuity). Ambient light by refraction system to the retina, the retinal photochemical reactions by bioelectrical, transmitted through the visual pathway visual cortex, the brain through a comprehensive analysis of the formation of vision. Any part of the distribution from the retina to the visual cortex nerve fibers, direction, known as the road lesions occur, it will be reflected in the vision, visual field changes according to the results of other tests and clinical, can analyze the site of the lesion, nature and prognosis
Catalog Number
-
Brand Name
NA
Version/Model Number
APS-6000AER
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
db18bd88-cdf4-4390-83a6-ec15db4ec973
Public Version Date
April 23, 2018
Public Version Number
1
DI Record Publish Date
March 22, 2018
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 | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |