K233409
- 510(k) number
- K233409
- Device name
- Eko Low Ejection Fraction Tool (ELEFT)
- Applicant
- Eko Health, Inc. CA · US
- Product code
- QYE — Reduced Ejection Fraction Machine Learning-Based Not
- Decision date
- 2024-03-28
- Date received
- 2023-10-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K233409.pdf
Official FDA record: K233409
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.