Resolve Fundus Camera
Optain Health, Inc.
OPTAIN HEALTH
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3038790635 | 3038790635 | OPTAIN HEALTH | 1 | N | 2026-01-01 | 526 S Main St Ste 211 Akron OH US 44311 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 341035 | 1611191905 | K250683 | Resolve Fundus Camera | HKI | 2025-04-30 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| HKI | 1 | 2025-04-30 |