510(k) K253109 ยท DQA Oximeter
Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)
| Applicant | Shenzhen Best Electronics Co., Ltd., Shenzhen, CN |
| Decision | Substantially Equivalent, Jan 7, 2026 |
| Received | Sep 24, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253109
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.