510(k) K232962 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Patient Monitor (iX10, iX12, iX15)
| Applicant | Edan Instruments, Inc., Shenzhen, CN |
| Decision | Substantially Equivalent, Apr 19, 2024 |
| Received | Sep 21, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232962
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 22, 2026 | Edan Diagnostics Brand Name: EDAN
Product Name: Patient Monitor
Model/Catalog Number: iX10, iX12, iX15
Product Description: The iX series Patient Monitors including iX10, iX12, iX15 can perform long-time continuous mo Open, Classified |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.