The following data is part of a premarket notification filed by Sas Oniris with the FDA for Oniris.
| Device ID | K150566 |
| 510k Number | K150566 |
| Device Name: | Oniris |
| Classification | Device, Anti-snoring |
| Applicant | SAS Oniris 704 Avenue Roger Salengro Chaville, FR 92370 |
| Contact | Thibault Vincent |
| Correspondent | Thibault Vincent SAS Oniris 704 Avenue Roger Salengro Chaville, FR 92370 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-06 |
| Decision Date | 2016-03-21 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ONIRIS 79160891 4788002 Live/Registered |
ONIRIS 2014-12-23 |
![]() ONIRIS 79160891 4788002 Live/Registered |
Mathieu VINCENT 2014-12-23 |
![]() ONIRIS 79160891 4788002 Live/Registered |
Thibault VINCENT 2014-12-23 |