The following data is part of a premarket notification filed by Centervue Spa with the FDA for Eidon Fa, Eidon, Eidon Af, Eidon Uwfl.
| Device ID | K211328 |
| 510k Number | K211328 |
| Device Name: | EIDON FA, EIDON, EIDON AF, EIDON UWFL |
| Classification | Ophthalmoscope, Laser, Scanning |
| Applicant | CenterVue SpA Via S. Marco 9H Padova, IT 35129 |
| Contact | Luca Scienza |
| Correspondent | Luca Scienza CenterVue SpA Via S. Marco 9H Padova, IT 35129 |
| Product Code | MYC |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-03 |
| Decision Date | 2021-08-19 |