510(k) K260140 ยท PHZ Abnormal Breath Sound Device
Aevice Wheeze Detection Module
| Applicant | Aevice Health Pte. , Ltd., Singapore, SG |
| Decision | Substantially Equivalent, Sep 25, 2026 |
| Received | Jan 20, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260140
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.