510(k) K171178 ยท HGM System, Monitoring, Perinatal
Central Monitoring System
| Applicant | Edan Instruments, Inc., Shenzhen, CN |
| Decision | Substantially Equivalent, Sep 6, 2017 |
| Received | Apr 21, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171178
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 22, 2026 | Edan Diagnostics Brand Name: EDAN
Product Name: Central Monitoring System
Model/Catalog Number: MFM-CNS, MFM-CNS Lite
Product Description: The MFM-CNS and MFM-CNS Lite are clinical data managing software applications. Open, Classified |
HGM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.