DEVICE: ELEFT (Eko Low Ejection Fraction Tool) (00850010298146)

Device Identifier (DI) Information

ELEFT (Eko Low Ejection Fraction Tool)
v7.x
In Commercial Distribution
ELEFT
Eko Devices, Inc.
00850010298146
GS1

1
079670921 *Terms of Use
Eko Low Ejection Fraction Tool (ELEFT) is a software intended to aid clinicians in identifying individuals with Left Ventricular Ejection Fraction (LVEF) less than or equal to 40%. ELEFT takes as input ECG and heart sounds and is intended for use on patients at risk for heart failure. This population includes, but is not limited to, patients with: coronary artery disease; diabetes mellitus; cardiomyopathy; hypertension; and obesity.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
47699 Cardiopulmonary physiological parameter analysis software
A software program designed to add image processing and/or data analysis capabilities to a computer/workstation for the interpretation and/or screening of cardiopulmonary physiological parameters [e.g., electrocardiogram (ECG), blood pressure, vital capacity (VC)]; data may be uploaded, or collected in real-time by connection (e.g., wired, Bluetooth) to other devices for spot-checks and/or continuous monitoring. It is intended for use exclusively by healthcare professionals and may provide risk assessment for cardiopulmonary events [e.g., acute myocardial infarction (AMI)] or screen for specific conditions (e.g., low ejection fraction). It might include machine learning (ML) technology.
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FDA Product Code

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Product Code Product Code Name
QYE Reduced Ejection Fraction Machine Learning-Based Notification Software
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K233409 000
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Sterilization

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Storage and Handling

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Storage and Handling
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

d18fd172-b9ae-4813-8c93-c54cc68b11d9
March 25, 2025
1
March 17, 2025
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Secondary DI

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Unit of Use DI

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Direct Marking (DM)

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Production Identifier(s) in UDI

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Customer Contact

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