Duns Number:338702316
Device Description: COMPASS is a scanning ophthalmoscope combined with an automatic perimeter that allows the COMPASS is a scanning ophthalmoscope combined with an automatic perimeter that allows the acquisition of images of the retina, as well as the measurement of retinal threshold sensitivity and the analysis of fixation..
Catalog Number
AMGSDME01
Brand Name
COMPASS
Version/Model Number
COMPASS
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
K150320
Product Code
HPT
Product Code Name
Perimeter, Automatic, Ac-Powered
Public Device Record Key
0327c702-73fb-41a9-b2db-cee70200f39c
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 03, 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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |