510(k) K254036 ยท HGM System, Monitoring, Perinatal
Novii+ Wireless Patch System
| Applicant | Datex Ohmeda, Inc., Waukesha WI, US |
| Decision | Substantially Equivalent, Aug 10, 2026 |
| Received | Dec 16, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254036
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.