K251695
- 510(k) number
- K251695
- Device name
- Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U203S-06); Unimed Reusable SpO2 Sensors (-06 Series) (U103S-06)
- Applicant
- Unimed Medical Supplies, Inc. CN
- Product code
- DQA — Oximeter
- Decision date
- 2025-11-18
- Date received
- 2025-06-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K251695.pdf
Official FDA record: K251695
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.