Eko Health, Inc.
FDA Regulatory Profile
Eko Health, Inc. appears in FDA public data with 0 recalls, 4 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on Jul 23, 2026.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 4
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K261694 | CORE 300 Digital Stethoscope | Jul 23, 2026 |
| K251494 | Eko Foundation Analysis Software with Transformers (EFAST) | Aug 12, 2025 |
| K233609 | CORE 500 Digital Stethoscope | Mar 28, 2024 |
| K233409 | Eko Low Ejection Fraction Tool (ELEFT) | Mar 28, 2024 |