The following data is part of a premarket notification filed by Cefla S.c. with the FDA for Newtom 7g.
| Device ID | K220664 |
| 510k Number | K220664 |
| Device Name: | NewTom 7G |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | CEFLA S.C. Via Selice Prov.le 23/ Imola, IT 40026 |
| Contact | Lorenzo Bortolotti |
| Correspondent | Lorenzo Bortolotti CEFLA S.C. Via Selice Prov.le 23/ Imola, IT 40026 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-07 |
| Decision Date | 2022-05-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033837932994 | K220664 | 000 |