Device type
Pulmonary Hypertension Machine Learning-Based Notification Software
Product code SAT · Class II · 21 CFR 870.2380 · Cardiovascular
Pulmonary hypertension machine learning-based notification software employs machine learning techniques to suggest the likelihood of pulmonary hypertension for further referral or diagnostic follow-up.
Recent 510(k)s
Aug 21, 2026
K253699
Tempus ECG-PH
Tempus AI, Inc.
- SAT
- Class II
Recent recalls
No recalls in the archive for SAT.