The following data is part of a premarket notification filed by Interacoustics A/s with the FDA for Eclipse With Vemp.
| Device ID | K162037 |
| 510k Number | K162037 |
| Device Name: | Eclipse With VEMP |
| Classification | Stimulator, Auditory, Evoked Response |
| 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 | GWJ |
| CFR Regulation Number | 882.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-22 |
| Decision Date | 2017-03-23 |
| Summary: | summary |