SAT — Pulmonary Hypertension Machine Learning-Based Notification Software Class II
FDA product code SAT covers "Pulmonary Hypertension Machine Learning-Based Notification Software", a Class II medical device regulated under 21 CFR 870.2380. Submissions are reviewed by the Cardiovascular panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- SAT
- Device Class
- Class II
- Regulation Number
- 870.2380
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
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.