510(k) K223848 · QUH Self-Fitting Air-Conduction Hearing Aid, Over The Counter
Intrisound Tuned Lumen® 155 Hearing Aids
| Applicant | Tuned , Ltd., Gan Yoshiya, IL |
| Decision | Substantially Equivalent, Sep 8, 2023 |
| Received | Dec 22, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223848
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.