510(k) K163326 ยท GWJ Stimulator, Auditory, Evoked Response
SmartEP
| Applicant | Intelligent Hearing Systems, Miami FL, US |
| Decision | Substantially Equivalent, Sep 29, 2017 |
| Received | Nov 28, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163326
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.