510(k) K241882 ยท HGM System, Monitoring, Perinatal
Fetal & Maternal Monitor (F15A, F15A Air)
| Applicant | Edan Instruments, Inc., Shenzhen, CN |
| Decision | Substantially Equivalent, Aug 27, 2025 |
| Received | Jun 28, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K241882
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.