K250837
- 510(k) number
- K250837
- Device name
- Pulse Oximeter
- Applicant
- Shanghai Berry Electronic Tech Co., Ltd. CN
- Product code
- DQA — Oximeter
- Decision date
- 2025-09-25
- Date received
- 2025-03-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K250837.pdf
Official FDA record: K250837
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.