510(k) K102140 ยท HGM System, Monitoring, Perinatal
FETAL MONITORS, MODELS F2 AND F3
| Applicant | Edan Instruments, Inc., Shenzhen, Guangdong, CN |
| Decision | Substantially Equivalent, Jan 13, 2011 |
| Received | Jul 29, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102140
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.