The following data is part of a premarket notification filed by Interacoustics A/s with the FDA for Nydiag 200.
| Device ID | K102364 |
| 510k Number | K102364 |
| Device Name: | NYDIAG 200 |
| Classification | Apparatus, Vestibular Analysis |
| 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 | LXV |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-20 |
| Decision Date | 2010-12-23 |
| Summary: | summary |