K250931
- 510(k) number
- K250931
- Device name
- Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U103-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U410-121); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U110-121)
- Applicant
- Unimed Medical Supplies, Inc. CN
- Product code
- DQA — Oximeter
- Decision date
- 2025-08-13
- Date received
- 2025-03-28
- 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: K250931.pdf
Official FDA record: K250931
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.