510(k) K202336 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Patient Monitor
| Applicant | Edan Instruments, Inc., Shenzhen, CN |
| Decision | Substantially Equivalent, Jan 23, 2021 |
| Received | Aug 17, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202336
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 22, 2026 | Edan Diagnostics Brand Name: EDAN
Product Name: Patient Monitor
Model/Catalog Number: iM50, iM60, iM70, iM80
Product Description: The iM series Patient Monitor including iM50, iM60, iM70 and iM80 can perform long-time Open, Classified |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.