The following data is part of a premarket notification filed by Centervue Spa with the FDA for Eidon.
| Device ID | K142047 |
| 510k Number | K142047 |
| Device Name: | EIDON |
| Classification | Ophthalmoscope, Laser, Scanning |
| Applicant | CENTERVUE SPA PIAZZA ALBANIA, 10 Rome, IT 00153 |
| Contact | Roger Gray |
| Correspondent | Roger Gray CENTERVUE SPA PIAZZA ALBANIA, 10 Rome, IT 00153 |
| Product Code | MYC |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-28 |
| Decision Date | 2014-11-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08053677040079 | K142047 | 000 |
| 08053677040062 | K142047 | 000 |
| 08053677040031 | K142047 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() EIDON 85510802 4725981 Live/Registered |
SGS Sports Inc. 2012-01-06 |
![]() EIDON 79324735 not registered Live/Pending |
Icare Finland Oy 2021-08-30 |
![]() EIDON 75305113 2203318 Live/Registered |
Eidon, Inc. 1997-06-09 |