2 devices · 1 company · 2024 to 2025
Eko Health, Inc.: AI-enabled devices on FDA's list
2 devices from Eko Health, Inc., 2024 to 2025, from 1 company across 2 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (2 of 2 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from Eko Health, Inc.
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| Eko Foundation Analysis Software with TransformeK251494 · 510(k) | Cardiovascular | DQD | database entry | |
| Eko Low Ejection Fraction ToolK233409 · 510(k) | Cardiovascular | QYE | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.