510(k) K221614 ยท PHZ Abnormal Breath Sound Device
TytoCare Lung Sounds Analyzer
| Applicant | Tyto Care , Ltd., Netanya, IL |
| Decision | Substantially Equivalent, Feb 24, 2023 |
| Received | Jun 3, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221614
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.