K233549
- 510(k) number
- K233549
- Device name
- Tempus ECG-AF
- Applicant
- Tempus AI, Inc. IL · US
- Product code
- SBQ — Atrial Fibrillation Risk Prediction Machine Learning
- Decision date
- 2024-06-21
- Date received
- 2023-11-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K233549.pdf
Official FDA record: K233549
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.