Eko Low Ejection Fraction Tool (ELEFT)— 510(k) K233409

Name: FDA 510(k) clearance K233409
Creator: U.S. Food and Drug Administration
Published: 2024-03-28

Substantially Equivalent

Eko Health, Inc.

FDA 510(k) clearance K233409 for Eko Low Ejection Fraction Tool (ELEFT), Substantially Equivalent on 2024-03-28. Applicant: Eko Health, Inc.. Device class: 2.

Clearance details

Applicant: Eko Health, Inc.
Product code: Code QYE
Device class: Class 2
Regulation: 21 CFR 870.2380
Advisory panel: Cardiovascular
Date received: 2023-10-06
Decision date: 2024-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Emeryville, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QYE

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K250649 — Bunkerhill ECG-EF2025-09-19
K250652 — ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)2025-07-28
K250119 — Tempus ECG-Low EF2025-07-15
K232699 — Low Ejection Fraction AI-ECG Algorithm2023-09-28

More clearances from Eko Health, Inc.

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K261694 — CORE 300 Digital Stethoscope2026-07-23
K251494 — Eko Foundation Analysis Software with Transformers (EFAST)2025-08-12
K233609 — CORE 500 Digital Stethoscope2024-03-28

Data sourced from openFDA. This site is unofficial and independent of the FDA.