FDA Product Code
FDA Product Code QYE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2380
510(k) Clearances — 6 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K254302 | ECG Analysis Software (AiTiALVSD) | Medical AI Co., Ltd. | 2026-09-30 | Traditional | PDF ↗ |
| K250649 | Bunkerhill ECG-EF | BunkerHill Health | 2025-09-19 | Traditional | PDF ↗ |
| K250652 | ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) | Anumana, Inc. | 2025-07-28 | Traditional | PDF ↗ |
| K250119 | Tempus ECG-Low EF | Tempus AI, Inc. | 2025-07-15 | Traditional | PDF ↗ |
| K233409 | Eko Low Ejection Fraction Tool (ELEFT) | Eko Health, Inc. | 2024-03-28 | Traditional | PDF ↗ |
| K232699 | Low Ejection Fraction AI-ECG Algorithm | Anumana, Inc. | 2023-09-28 | Traditional | PDF ↗ |
Product code QYE · Class II · Cardiovascular. Data: openFDA.