510(k) K253673 · LQK Home Uterine Activity Monitor
Mcare System (MW-20)
| Applicant | Marani Health, Inc., Oakdale MN, US |
| Decision | Substantially Equivalent, Sep 3, 2026 |
| Received | Nov 21, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253673
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.