510(k) K131818 ยท DQA Oximeter
VITAL SIGNS MONITOR
| Applicant | Edan Instruments, Inc., Shenzhen, Guangdong, CN |
| Decision | Substantially Equivalent, Aug 30, 2013 |
| Received | Jun 20, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K131818
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 22, 2026 | Edan Diagnostics Brand Name: EDAN
Product Name: Vital Signs Monitor
Model/Catalog Number: M3
Product Description: The Vital Signs Monitor is a portable device intended for use by health care professionals. The monitor Open, Classified |
DQA | None listed |
| Jan 22, 2026 | Edan Diagnostics Brand Name: EDAN
Product Name: Vital Signs Monitor
Model/Catalog Number: M3A
Product Description: The Vital Signs Monitor is a portable device intended for use by health care professionals. The monito Open, Classified |
DQA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.