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510(k) K233409

Eko Low Ejection Fraction Tool (ELEFT) by Eko Health, Inc. — Product Code QYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2024
Date Received
October 6, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reduced Ejection Fraction Machine Learning-Based Notification Software
Device Class
Class II
Regulation Number
870.2380
Review Panel
CV
Submission Type

Reduced Ejection Fraction machine learning-based notification software employs machine learning techniques to suggest the likelihood of a reduced ejection fraction for further referral or diagnostic follow-up.

Other clearances by Eko Health, Inc.

  • K251494 — Eko Foundation Analysis Software with Transformers (EFAST) (August 12, 2025)
  • K233609 — CORE 500 Digital Stethoscope (March 28, 2024)

Other clearances for product code QYE

  • K250649 — Bunkerhill ECG-EF (September 19, 2025)
  • K250652 — ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) (July 28, 2025)
  • K250119 — Tempus ECG-Low EF (July 15, 2025)
  • K232699 — Low Ejection Fraction AI-ECG Algorithm (September 28, 2023)