The following data is part of a premarket notification filed by Dental X-ray E.u. with the FDA for Elity 70 X-ray.
| Device ID | K043136 |
| 510k Number | K043136 |
| Device Name: | ELITY 70 X-RAY |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | DENTAL X-RAY E.U. 1460 NW 107 AVE SUITE G Miami, FL 33172 |
| Contact | George Echeverri |
| Correspondent | George Echeverri DENTAL X-RAY E.U. 1460 NW 107 AVE SUITE G Miami, FL 33172 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-12 |
| Decision Date | 2005-01-06 |
| Summary: | summary |