The following data is part of a premarket notification filed by Cefla Sc with the FDA for Rx Dc.
| Device ID | K163519 |
| 510k Number | K163519 |
| Device Name: | RX DC |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | CEFLA SC VIA SELICE PROV. LE 23/A Imola, IT 40026 |
| Contact | Bortolotti Lorenzo |
| Correspondent | Maurizio Pantaleoni ISEMED SRL VIA ARGENTINA ALTOBELLI BONETTI 3A Imola, IT 40026 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-15 |
| Decision Date | 2017-01-13 |
| Summary: | summary |