510(k) K231964 ยท HGM System, Monitoring, Perinatal
Novii+ Wireless Patch System
| Applicant | Datex Ohmeda, Wauwatosa WI, US |
| Decision | Substantially Equivalent, Dec 8, 2023 |
| Received | Jul 3, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231964
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.