510(k) K061443 ยท GWJ Stimulator, Auditory, Evoked Response
SMART USBLITE, MODEL M011120
| Applicant | Intelligent Hearing Systems, Miami FL, US |
| Decision | Substantially Equivalent, Jun 23, 2006 |
| Received | May 24, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K061443
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.