510(k) K231550 · QUH Self-Fitting Air-Conduction Hearing Aid, Over The Counter
Sontro® OTC Hearing Aids (AI)
| Applicant | Soundwave Hearing, LLC, Oak Brook IL, US |
| Decision | Substantially Equivalent, Oct 26, 2023 |
| Received | May 30, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231550
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.