Device Classification Name |
home monitoring ophthalmic optical coherence tomography (oct) imaging device
|
De Novo Number |
DEN230043 |
Device Name |
Notal Vision Home Optical Coherence Tomography (OCT) System |
Requester |
Notal Vision Inc |
7717 coppermine drive |
manassas,
VA
20109
|
|
Contact |
kester nahen |
|
Regulation Number | 886.1600
|
Classification Product Code |
|
Date Received | 06/07/2023 |
Decision Date | 05/15/2024 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Ophthalmic
|
Review Advisory Committee |
Ophthalmic
|
Reclassification Order |
Reclassification Order
|
Type |
Direct
|
|
|