510(k) K180380 ยท DQA Oximeter
vital signs monitor
| Applicant | Edan Instruments, Inc., Shenzhen, CN |
| Decision | Substantially Equivalent, Dec 21, 2018 |
| Received | Feb 12, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180380
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 22, 2026 | Edan Diagnostics Brand Name: EDAN
Product Name: Vital Signs Monitor
Model/Catalog Number: iM3
Product Description: The iM3 has three work modes, Monitor, Spot and Round, to measure physiological parameters, including Open, Classified |
DQA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.