The following data is part of a premarket notification filed by Interacoustics A/s with the FDA for Trv.
| Device ID | K192652 |
| 510k Number | K192652 |
| Device Name: | TRV |
| Classification | Apparatus, Vestibular Analysis |
| Applicant | Interacoustics A/S Audiometer Alle 1 Middelfart, DK 5500 |
| Contact | Erik Nielsen |
| Correspondent | Erik Nielsen Interacoustics A/S Audiometer Alle 1 Middelfart, DK 5500 |
| Product Code | LXV |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-24 |
| Decision Date | 2020-05-27 |