510(k) K250777 ยท HGM System, Monitoring, Perinatal
Sonicaid Team3
| Applicant | Huntleigh Healthcare , Ltd., Cardiff, GB |
| Decision | Substantially Equivalent, Sep 19, 2025 |
| Received | Mar 14, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250777
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.