510(k) K152552 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Patient Monitor
| Applicant | Edan Instruments, Inc., Shenzhen, CN |
| Decision | Substantially Equivalent, Apr 29, 2016 |
| Received | Sep 8, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152552
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 22, 2026 | Edan Diagnostics Brand Name: EDAN
Product Name: Patient Monitor
Model/Catalog Number: iM20
Product Description: The iM20 Patient Monitor System (hereinafter called iM20) can perform long-time continuous monitoring of Open, Classified |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.