Eko Low Ejection Fraction Tool (ELEFT)— 510(k) K233409
Substantially EquivalentEko Health, Inc.
FDA 510(k) clearance K233409 for Eko Low Ejection Fraction Tool (ELEFT), Substantially Equivalent on 2024-03-28. Applicant: Eko Health, Inc..
Clearance details
- Applicant
- Eko Health, Inc.
- Product code
- Code QYE
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Emeryville, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.