The following data is part of a premarket notification filed by Fona S.r.l with the FDA for Starx-1, Starx-2, Starx Pro-1 And Starx Pro-2.
| Device ID | K212103 |
| 510k Number | K212103 |
| Device Name: | StarX-1, StarX-2, StarX PRO-1 And StarX PRO-2 |
| 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 | 2021-07-06 |
| Decision Date | 2021-08-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E31593800012000 | K212103 | 000 |
| E31593800011000 | K212103 | 000 |
| E31593800002000 | K212103 | 000 |
| E31593800001000 | K212103 | 000 |