The following data is part of a premarket notification filed by Centervue Spa with the FDA for Eidon Fa.
| Device ID | K180526 |
| 510k Number | K180526 |
| Device Name: | EIDON FA |
| Classification | Ophthalmoscope, Laser, Scanning |
| Applicant | CenterVue SpA Via S. Marco 9H Padova, IT 35129 |
| Contact | Roberto Gabriotti |
| Correspondent | Roberto Gabriotti CenterVue SpA Via S. Marco 9H Padova, IT 35129 |
| Product Code | MYC |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-27 |
| Decision Date | 2018-07-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08053677040093 | K180526 | 000 |