The following data is part of a premarket notification filed by Gn Otometrics A/s with the FDA for Ics Chartr Ep 200 With Vemp.
| Device ID | K143670 |
| 510k Number | K143670 |
| Device Name: | ICS CHARTR EP 200 WITH VEMP |
| Classification | Stimulator, Auditory, Evoked Response |
| Applicant | GN OTOMETRICS A/S HOERSKAETTEN 9 Taastrup Region Hovedstaden, DK Dk-2630 |
| Contact | Anders Rasmussen |
| Correspondent | Daniel Kamm KAMM & ASSOCIATES 8870 RAVELLO CT Naples, FL 34114 |
| Product Code | GWJ |
| CFR Regulation Number | 882.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-24 |
| Decision Date | 2015-10-23 |
| Summary: | summary |