The following data is part of a premarket notification filed by Fona S.r.l with the FDA for Fona Xdc.
| Device ID | K222274 |
| 510k Number | K222274 |
| Device Name: | FONA XDC |
| Classification | Unit, X-ray, Extraoral With Timer |
| 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 | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-29 |
| Decision Date | 2022-08-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E3159319001700 | K222274 | 000 |