510(k) K073384 ยท GWJ Stimulator, Auditory, Evoked Response
SMART COUPLER, MODEL M015401
| Applicant | Intelligent Hearing Systems, Miami FL, US |
| Decision | Substantially Equivalent, Feb 28, 2008 |
| Received | Dec 3, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K073384
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.