510(k) K160981 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Patient Monitor
| Applicant | Edan Instruments, Inc., Shenzhen, CN |
| Decision | Substantially Equivalent, Dec 22, 2016 |
| Received | Apr 7, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160981
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 22, 2026 | Edan Diagnostics Brand Name: EDAN
Product Name: Patient Monitor
Model/Catalog Number: elite V5, elite V6, elite V8
Product Description: V series Patient Monitor including elite V5, elite V6 and elite V8 which can perf Open, Classified |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.