510(k) K231545 ยท EWO Audiometer
hearOAE
| Applicant | Hearx SA (Pty) , Ltd., Pretoria, ZA |
| Decision | Substantially Equivalent, Oct 27, 2023 |
| Received | May 30, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231545
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.