FDA 510(k) Applications for Medical Device Product Code "QYE"
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K232699 | Anumana, Inc. | Low Ejection Fraction AI-ECG Algorithm | 09/28/2023 |
| K233409 | Eko Health, Inc. | Eko Low Ejection Fraction Tool (ELEFT) | 03/28/2024 |
| K250119 | Tempus AI, Inc. | Tempus ECG-Low EF | 07/15/2025 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
