K250119
- 510(k) number
- K250119
- Device name
- Tempus ECG-Low EF
- Applicant
- Tempus AI, Inc. IL · US
- Product code
- QYE — Reduced Ejection Fraction Machine Learning-Based Not
- Decision date
- 2025-07-15
- Date received
- 2025-01-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K250119.pdf
Official FDA record: K250119
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.