K253109
- 510(k) number
- K253109
- Device name
- Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)
- Applicant
- Shenzhen Best Electronics Co., Ltd. CN
- Product code
- DQA — Oximeter
- Decision date
- 2026-01-07
- Date received
- 2025-09-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K253109.pdf
Official FDA record: K253109
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.