510(k) K100661 ยท GWJ Stimulator, Auditory, Evoked Response
EARPROBE
| Applicant | Path Medical GmbH, Fort Collins CO, US |
| Decision | Substantially Equivalent, Jul 1, 2010 |
| Received | Mar 8, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100661
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 18, 2025 | PATH MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100) Open, Classified |
GWJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.