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.
v7.x
In Commercial Distribution
ELEFT
Eko Devices, Inc.
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]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? |
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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
[?]Product Code | Product Code Name |
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QYE | Reduced Ejection Fraction Machine Learning-Based Notification Software |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K233409 | 000 |
Sterilization
Storage and Handling
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Clinically Relevant Size
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Device Record Status
d18fd172-b9ae-4813-8c93-c54cc68b11d9
March 25, 2025
1
March 17, 2025
March 25, 2025
1
March 17, 2025
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Unit of Use DI
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CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined