510(k) K251691 ยท DQA Oximeter
Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U203S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103-08)
| Applicant | Unimed Medical Supplies, Inc., Shenzhen, CN |
| Decision | Substantially Equivalent, Dec 1, 2025 |
| Received | Jun 2, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251691
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.