510(k) K232694 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Central Monitoring System (MFM-CMS)
| Applicant | Edan Instruments, Inc., Shenzhen, CN |
| Decision | Substantially Equivalent, Feb 5, 2024 |
| Received | Sep 5, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232694
| 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-CMS
Product Description: MFM-CMS is a central monitoring system product, which can connect and manage information fro Open, Classified |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.