510(k) K101539 ยท DQA Oximeter
VITAL SIGNS MONITOR MODEL M3B
| Applicant | Edan Instruments, Inc., Shenzhen, Guangdong, CN |
| Decision | Substantially Equivalent, Nov 24, 2010 |
| Received | Jun 3, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101539
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 22, 2026 | Edan Diagnostics Brand Name: EDAN
Product Name: Vital Signs Monitor
Model/Catalog Number: M3B
Product Description: M3B Vital Signs Monitor is a patient monitoring device providing the patient with a continuous vital p Open, Classified |
DQA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.