Duns Number:346013337
Device Description: The P200TE is a non-contact scanning laser ophthalmoscope and optical coherence tomographe The P200TE is a non-contact scanning laser ophthalmoscope and optical coherence tomographer intended for in-vivo viewing and digital imaging of posterior ocular structures, including the retina, retinal nerve fiber layer and optic disc.
Catalog Number
A10700
Brand Name
OCT Ophthalmoscope
Version/Model Number
P200TE
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
MYC
Product Code Name
Ophthalmoscope,Laser,Scanning
Public Device Record Key
1ae8c9de-f4c7-444b-9ba6-61365832f161
Public Version Date
May 03, 2018
Public Version Number
1
DI Record Publish Date
April 02, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |