The following data is part of a premarket notification filed by Gn Otometrics with the FDA for Ics Chartr Ep 200.
| Device ID | K092373 |
| 510k Number | K092373 |
| Device Name: | ICS CHARTR EP 200 |
| Classification | Stimulator, Auditory, Evoked Response |
| Applicant | GN OTOMETRICS 333 MILFORD RD Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm GN OTOMETRICS 333 MILFORD RD Deerfield, IL 60015 |
| Product Code | GWJ |
| CFR Regulation Number | 882.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-05 |
| Decision Date | 2009-09-03 |
| Summary: | summary |