The following data is part of a premarket notification filed by Interacoustics A/s with the FDA for At235.
| Device ID | K151616 |
| 510k Number | K151616 |
| Device Name: | AT235 |
| Classification | Tester, Auditory Impedance |
| Applicant | INTERACOUSTICS A/S DREJERVAENGET 8 Assens, DK Dk-5610 |
| Contact | Erik Nielsen |
| Correspondent | Erik Nielsen INTERACOUSTICS A/S DREJERVAENGET 8 Assens, DK Dk-5610 |
| Product Code | ETY |
| CFR Regulation Number | 874.1090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-15 |
| Decision Date | 2015-07-15 |
| Summary: | summary |