510(k) K233038 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s
| Applicant | Edan Instruments, Inc., Shenzhen, CN |
| Decision | Substantially Equivalent, Mar 8, 2024 |
| Received | Sep 25, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233038
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 22, 2026 | Edan Diagnostics Brand Name: EDAN
Product Name: Vital Signs Monitor
Model/Catalog Number: iM3s, iM3As, iM3Bs, iHM3s
Product Description: The iM3s series vital signs monitors including iM3s/iM3As/iM3Bs/iHM3s are intend Open, Classified |
MWI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.