Product code SAT
- Device name
- Pulmonary Hypertension Machine Learning-Based Notification Software
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.2380
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- 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.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|
| K252360 | ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) | Anumana, Inc. | 2026-03-28 |
| K233666 | CorVista System with PH Add-On | Analytics For Life, Inc. | 2024-04-05 |
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|
| 00869059000443 | CorVista® System with PH Add-On | Analytics For Life Inc | 2024-04-19 |