Eko Health, Inc.
FDA 510(k) & PMA Approved Devices — 4 products
Total Devices4
Categories2
Latest FDA decision2026-07-23
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K261694 | CORE 300 Digital Stethoscope | DQD | 2026-07-23 | View |
| 510(k) | K251494 | Eko Foundation Analysis Software with Transformers (EFAST) | DQD | 2025-08-12 | View |
| 510(k) | K233609 | CORE 500 Digital Stethoscope | DQD | 2024-03-28 | View |
| 510(k) | K233409 | Eko Low Ejection Fraction Tool (ELEFT) | QYE | 2024-03-28 | View |
No matching devices.