The following data is part of a premarket notification filed by Cefla S.c. with the FDA for Newtom 5g Xl.
| Device ID | K183448 |
| 510k Number | K183448 |
| Device Name: | NewTom 5G XL |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | Cefla S.C. Via Selice Provinciale 23/A Imola, IT 40026 |
| Contact | Elena Arcangeli |
| Correspondent | Elena Arcangeli Cefla S.C. Via Selice Provinciale 23/A 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 | 2018-12-12 |
| Decision Date | 2019-03-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033837931379 | K183448 | 000 |