The following data is part of a premarket notification filed by Soredex Palodex Group Oy with the FDA for Cranex Basex D Or Cranex Excel D.
| Device ID | K040382 |
| 510k Number | K040382 |
| Device Name: | CRANEX BASEX D OR CRANEX EXCEL D |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | SOREDEX PALODEX GROUP OY ELIMAENKATU 22 B Helsinki, FI Fin-00510 |
| Contact | Kai Laner |
| Correspondent | Kai Laner SOREDEX PALODEX GROUP OY ELIMAENKATU 22 B Helsinki, FI Fin-00510 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-17 |
| Decision Date | 2004-07-13 |
| Summary: | summary |