510(k) K173042 ยท HGM System, Monitoring, Perinatal
Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3
| Applicant | Edan Instruments, Inc., Shenzhen, CN |
| Decision | Substantially Equivalent, Aug 30, 2018 |
| Received | Sep 28, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173042
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 22, 2026 | Edan Diagnostics Brand Name: EDAN
Product Name: Fetal Monitor
Model/Catalog Number: F2, F3
Product Description: The devices are bedside fetal and maternal monitors, which are used to monitor the physiological paramete Open, Classified |
HGM | None listed |
| 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.