510(k) K254000 ยท DXN System, Measurement, Blood-Pressure, Non-Invasive
Happy Health Blood Pressure Monitor
| Applicant | Happy Health, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Sep 3, 2026 |
| Received | Dec 15, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254000
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.