The following data is part of a premarket notification filed by Trophy Radiologie with the FDA for Elitys Or Elitys-e.
| Device ID | K962337 |
| 510k Number | K962337 |
| Device Name: | ELITYS OR ELITYS-E |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | TROPHY RADIOLOGIE 106, RUE DE LA JARRY B.P. 20 Vincennes, Cedex (paris), FR 94307 |
| Contact | Marie Pierre Labat-camy |
| Correspondent | Marie Pierre Labat-camy TROPHY RADIOLOGIE 106, RUE DE LA JARRY B.P. 20 Vincennes, Cedex (paris), FR 94307 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-17 |
| Decision Date | 1996-07-25 |