510(k) K252844 ยท PHZ Abnormal Breath Sound Device
Tyto Insights for Wheeze Detection (with PCCP)
| Applicant | Tyto Care , Ltd., Netanya, IL |
| Decision | Substantially Equivalent, Jun 2, 2026 |
| Received | Sep 8, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252844
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.