The following data is part of a premarket notification filed by Audio Technologies S.r.l. with the FDA for Audio Technologies S:r.1.
| Device ID | K001142 |
| 510k Number | K001142 |
| Device Name: | AUDIO TECHNOLOGIES S:R.1 |
| Classification | Prosthesis, Partial Ossicular Replacement |
| Applicant | AUDIO TECHNOLOGIES S.R.L. VIA DELL'ARTIGINATO, 8 GOSSOLENGO Piacenza, IT 29020 |
| Contact | Franco Beoni |
| Correspondent | Franco Beoni AUDIO TECHNOLOGIES S.R.L. VIA DELL'ARTIGINATO, 8 GOSSOLENGO Piacenza, IT 29020 |
| Product Code | ETB |
| CFR Regulation Number | 874.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-10 |
| Decision Date | 2000-06-23 |