Emeryville, CA, US · 4 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| DQD | Stethoscope, Electronic | Class II | Cardiovascular | 3 | 2026-07-23 |
| QYE | — | — | — | 1 | 2024-03-28 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-07-23 | K261694 | CORE 300 Digital Stethoscope | DQD | Class II | Cardiovascular |
| 2025-08-12 | K251494 | Eko Foundation Analysis Software with Transformers (EFAST) | DQD | Class II | Cardiovascular |
| 2024-03-28 | K233609 | CORE 500 Digital Stethoscope | DQD | Class II | Cardiovascular |
| 2024-03-28 | K233409 | Eko Low Ejection Fraction Tool (ELEFT) | QYE | — | — |