Eyer Retinal Camera NM-STD
Phelcom Technologies
PHELCOM TECHNOLOGIES
FDA Registration(s)
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3017175640 | 3017175640 | PHELCOM TECHNOLOGIES | 1 | N | 2026-01-01 | Rua Jose Missali, 820 Santa Felicia Sao Carlos Sao Paulo BR 13562-405 |
| 3023549866 | 3023549866 | PHELCOM TECHNOLOGIES LLC | 1 | Y | 2026-01-01 | 245 Main St, 2nd floor CIC Cambridge MA US 02142 |
Registered Device Listings
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 274248 | 1152776289 | K251353 | Eyer 2 | HKI | 2026-01-16 |
| 274248 | 1955628861 | K221329 | Eyer Retinal Camera NM-STD | HKI | 2023-02-22 |
| 274248 | 1042347402 |
Product Codes Associated With Registrations
| Product code | Registration listing records | Latest decision |
|---|---|---|
| HKI | 2 | 2026-01-16 |
PMN
GUDID
Eyer 2 Basic
2024-09-23
Eyer - Eyer Retinal Camera M-STD
2023-04-27
Eyer - Eyer Retinal Camera NM-STD
2023-04-27