510(k) K243567 ยท PHZ Abnormal Breath Sound Device
Tyto Insights for Rhonchi Detection
| Applicant | Tyto Care , Ltd., Netanya, IL |
| Decision | Substantially Equivalent, Apr 7, 2025 |
| Received | Nov 18, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243567
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.