The following data is part of a premarket notification filed by Fona S.r.l with the FDA for Stellaris 2d, Stellaris 2d Ceph, Stellaris 3d And Stellaris 3d Ceph.
| Device ID | K213579 |
| 510k Number | K213579 |
| Device Name: | Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D And Stellaris 3D Ceph |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | FONA S.r.l Via G.Galilei 11 Assago, IT 20057 |
| Contact | Luigi Germano |
| Correspondent | Krupa Srivastava FONA S.r.l Via G.Galilei 11 Assago, IT 20057 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-10 |
| Decision Date | 2022-03-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E3158468600008 | K213579 | 000 |
| E3158468600007 | K213579 | 000 |
| E3158468600002 | K213579 | 000 |
| E3158468600000 | K213579 | 000 |