510(k) K253021 ยท HGM System, Monitoring, Perinatal
ANNE Maternal
| Applicant | Sibel Health, Inc., Chicago IL, US |
| Decision | Substantially Equivalent, Feb 26, 2026 |
| Received | Sep 19, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253021
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.