510(k) clearance
Tempus ECG-PH
- 510(k) number
- K253699
- Applicant
- Tempus AI, Inc.
- Decision date
- Aug 21, 2026
- Date received
- Nov 24, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- SAT
- Device type
- Pulmonary Hypertension Machine Learning-Based Notification Software
- Device class
- Class II
- Regulation
- 21 CFR 870.2380
- Advisory committee
- Cardiovascular
- Statement or summary
- Summary
- Third party
- N
- Location
- Chicago, IL, US