510(k) K083399 ยท GWJ Stimulator, Auditory, Evoked Response
ICS CHARTR EP 200
| Applicant | Gn Otometrics A/S, Schaumburg IL, US |
| Decision | Substantially Equivalent, Feb 20, 2009 |
| Received | Nov 17, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083399
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 28, 2019 | GN Otometrics The ICS CHARTR EP 200 Terminated |
GWJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.