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 |