510(k) K150901 ยท HGM System, Monitoring, Perinatal
Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express
| Applicant | Edan Instruments, Inc., Shenzhen, CN |
| Decision | Substantially Equivalent, Jul 1, 2015 |
| Received | Apr 3, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150901
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 22, 2026 | Edan Diagnostics Brand Name: EDAN
Product Name: Fetal & Maternal Monitor
Model/Catalog Number: F6, F9, F6 Express, F9 Express
Product Description: The devices are bedside fetal and maternal monitors, which are used to Open, Classified |
HGM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.