Anumana, Inc.
FDA 510(k) & PMA Approved Devices — 5 products
Total Devices5
Categories4
Latest Approval2026-04-07
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K253801 | ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) | SHP | 2026-04-07 | View |
| 510(k) | K252360 | ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) | SAT | 2026-03-28 | View |
| 510(k) | K250652 | ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) | QYE | 2025-07-28 | View |
| 510(k) | K233160 | NeuTrace EP Mapping System v.2.1 | DQK | 2023-11-25 | View |
| 510(k) | K232699 | Low Ejection Fraction AI-ECG Algorithm | QYE | 2023-09-28 | View |
No matching devices.