K253699
- 510(k) number
- K253699
- Device name
- Tempus ECG-PH
- Applicant
- Tempus AI, Inc. IL · US
- Product code
- SAT — Pulmonary Hypertension Machine Learning-Based Notifi
- Decision date
- 2026-08-21
- Date received
- 2025-11-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
510(k) Summary (official FDA PDF): K253699.pdf
Official FDA record: K253699
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.