FDA Product Code
FDA Product Code SAT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2380
510(k) Clearances — 3 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253699 | Tempus ECG-PH | Tempus AI, Inc. | 2026-08-21 | Traditional | PDF ↗ |
| K252360 | ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) | Anumana, Inc. | 2026-03-28 | Traditional | PDF ↗ |
| K233666 | CorVista System with PH Add-On | Analytics For Life, Inc. | 2024-04-05 | Traditional | PDF ↗ |
Product code SAT · Class II · Cardiovascular. Data: openFDA.