The following data is part of a premarket notification filed by Villa Sistemi Medicali S.p.a. with the FDA for Aztech 70.
| Device ID | K984524 |
| 510k Number | K984524 |
| Device Name: | AZTECH 70 |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | VILLA SISTEMI MEDICALI S.P.A. 1401 WALNUT ST. SUITE 565 Boulder, CO 80302 |
| Contact | Al Sosa |
| Correspondent | Al Sosa VILLA SISTEMI MEDICALI S.P.A. 1401 WALNUT ST. SUITE 565 Boulder, CO 80302 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-21 |
| Decision Date | 1999-01-14 |
| Summary: | summary |