510(k) K223137 ยท QUH Self-Fitting Air-Conduction Hearing Aid, Over The Counter
Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application
| Applicant | Hearx SA (Pty) , Ltd., Pretoria, ZA |
| Decision | Substantially Equivalent, Mar 14, 2023 |
| Received | Oct 4, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223137
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.