CADENCE - Camera, Ophthalmic, ac-powered
2020-02-24
RETINA-AI HEALTH, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3016516790 | 3016516790 | RETINA-AI HEALTH, INC. | 1 | Y | 2020-04-25 | 3838 N braeswood Blvd 427 Houston TX US 77025 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 238572 | 1189046116 | K182199 | NFC-700 non-mydriatic auto fundus camera | HKI | 2019-01-02 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| HKI | 1 | 2019-01-02 |