510(k) K243437 ยท FMZ Incubator, Neonatal
mOm Essential Incubator (ME1)
| Applicant | Mom Incubators Limited, Nottingham, GB |
| Decision | Substantially Equivalent, Aug 14, 2025 |
| Received | Nov 5, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243437
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.