CORE 500 Digital Stethoscope
Eko Devices, Inc.
Eko Devices, Inc.
PMN#
Eko Murmur Analysis Software (EMAS)
Eko Devices, Inc.
Eko CORE
Eko Devices, Inc.
Eko Analysis Software
Eko Devices Inc
Eko Model E5 System (EME5), Eko DUO
Eko Devices, Inc.
Eko Electronic Stethoscope System
Eko Devices, Inc.
GUDID#
CORE 500 Digital Stethoscope - Bundle-ROG - The CORE 500 Digital Stethoscope is intended to be used by clinicians to electronically amplify, filter, and transfer body sounds and three lead electrocardiogram (ECG) waveforms. The CORE 500 Digital Stethoscope also displays ECG waveforms and heart rate on the display and accompanying mobile application (when prescribed or used under the care of a clinician).The data offered by the device is only significant when used in conjunction with clinician evaluation as well as consideration of other relevant patient data.
2026-04-03
CORE 500 Digital Stethoscope - Rose Gold Earpiece - The CORE 500 Digital Stethoscope is intended to be used by clinicians to electronically amplify, filter, and transfer body sounds and three lead electrocardiogram (ECG) waveforms. The CORE 500 Digital Stethoscope also displays ECG waveforms and heart rate on the display and accompanying mobile application (when prescribed or used under the care of a clinician).The data offered by the device is only significant when used in conjunction with clinician evaluation as well as consideration of other relevant patient data.
2026-04-03
CORE 500 Digital Stethoscope - Rose Gold Chestpiece - The CORE 500 Digital Stethoscope is intended to be used by clinicians to electronically amplify, filter, and transfer body sounds and three lead electrocardiogram (ECG) waveforms. The CORE 500 Digital Stethoscope also displays ECG waveforms and heart rate on the display and accompanying mobile application (when prescribed or used under the care of a clinician).The data offered by the device is only significant when used in conjunction with clinician evaluation as well as consideration of other relevant patient data.
2026-04-03
CORE 500 Digital Stethoscope FIGS Earpiece - Orange Taffy - The CORE 500 Digital Stethoscope is intended to be used by clinicians to electronically amplify, filter, and transfer body sounds and three lead electrocardiogram (ECG) waveforms. The CORE 500 Digital Stethoscope also displays ECG waveforms and heart rate on the display and accompanying mobile application (when prescribed or used under the care of a clinician).The data offered by the device is only significant when used in conjunction with clinician evaluation as well as consideration of other relevant patient data.
2026-04-03
CORE 500 Digital Stethoscope FIGS Earpiece - Rapid Response Pink - The CORE 500 Digital Stethoscope is intended to be used by clinicians to electronically amplify, filter, and transfer body sounds and three lead electrocardiogram (ECG) waveforms. The CORE 500 Digital Stethoscope also displays ECG waveforms and heart rate on the display and accompanying mobile application (when prescribed or used under the care of a clinician).The data offered by the device is only significant when used in conjunction with clinician evaluation as well as consideration of other relevant patient data.
2026-04-03
EFAST (Eko Foundation Analysis Software with Transformers) - The Eko Foundation Analysis Software with Transformers (EFAST) is intended to support healthcare professionals in the evaluation of patients’ heart sounds and electrocardiograms (ECGs). The software calculates heart rate, detects the presence of murmurs associated with Structural Heart Disease, and determines murmur timing including the timing of S1, S2 heart sounds. When ECG is available, the software detects the presence of atrial fibrillation and normal sinus rhythm. The software is intended for use by or under the supervision of a healthcare professional and is not to be used as a sole means of diagnosis. The interpretations of heart sounds and ECG offered by the software are designed to support and not replace the healthcare professional’s clinical judgment. The murmur detection is intended for use on both pediatric and adult patients, while the detection of atrial fibrillation is intended for use on adults (> 18 years).
2026-01-29
CORE 500 Digital Stethoscope FIGS Earpiece - Caribbean Blue - The CORE 500™ Digital Stethoscope is intended to be used by clinicians or lay users to electronically amplify, filter, and transfer body sounds and three lead electrocardiogram (ECG) waveforms. The CORE 500™ Digital Stethoscope also displays ECG waveforms and heart rate on the display and accompanying mobile application (when prescribed or used under the care of a clinician or by lay users).A lay user is not intended to interpret or take clinical action based on the device output without consulting with a qualified healthcare professional.
2026-01-29
Eko Analysis Software - The Eko Analysis Software is intended to provide support to the physician in the evaluation of patients' heart soundsand ECG’s. The software analyzes simultaneous ECG and heart sounds. The software will detect the presence ofsuspected murmurs in the heart sounds. The software also detects the presence of atrial fibrillation and normalsinus rhythm from the ECG signal. In addition, it calculates certain cardiac time intervals such as heart rate, QRSduration and EMAT. The software does not distinguish between different kinds of murmurs and does not identifyother arrhythmias.It is not intended as a sole means of diagnosis. The interpretations of heart sounds and ECG offered by the softwareare only significant when used in conjunction with physician over-read and is for use on adults (> 18 years)
2020-09-08
EMAS (Eko Murmur Analysis Software) - The Eko Murmur Analysis Software is intended to provide decision support to clinicians in their evaluation of patients’ heart sounds. The software analyzes heart sounds and phonocardiograms (and ECG signals, when available). The software will automatically detect murmurs that may be present, and the murmur timing and character, including S1, S2, innocent heart murmurs, structural heart murmurs, and the absence of a heart murmur.
2025-03-17
ELEFT (Eko Low Ejection Fraction Tool) - 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.
2025-03-17
CORE 500 Digital Stethoscope - Cool Blue Earpiece - The CORE 500 Digital Stethoscope is intended to be used by clinicians or lay users to electronically amplify, filter, and transfer body sounds and three lead electrocardiogram (ECG) waveforms. The CORE 500 Digital Stethoscope also displays ECG waveforms and heart rate on the display and accompanying mobile application (when prescribed or used under the care of a clinician or by lay users).A lay user is not intended to interpret or take clinical action based on the device output without consulting with a qualified healthcare professional.
2025-11-07
CORE 500 Digital Stethoscope - Cool Blue Chestpiece - The CORE 500 Digital Stethoscope is intended to be used by clinicians or lay users to electronically amplify, filter, and transfer body sounds and three lead electrocardiogram (ECG) waveforms. The CORE 500 Digital Stethoscope also displays ECG waveforms and heart rate on the display and accompanying mobile application (when prescribed or used under the care of a clinician or by lay users).A lay user is not intended to interpret or take clinical action based on the device output without consulting with a qualified healthcare professional.
2025-11-07
CORE 500 Digital Stethoscope FIGS Earpiece - Off White - The CORE 500™ Digital Stethoscope is intended to be used by clinicians or lay users to electronically amplify, filter, and transfer body sounds and three lead electrocardiogram (ECG) waveforms. The CORE 500™ Digital Stethoscope also displays ECG waveforms and heart rate on the display and accompanying mobile application (when prescribed or used under the care of a clinician or by lay users).A lay user is not intended to interpret or take clinical action based on the device output without consulting with a qualified healthcare professional.
2025-10-15
CORE 500 Digital Stethoscope FIGS Earpiece - Elderberry - The CORE 500™ Digital Stethoscope is intended to be used by clinicians or lay users to electronically amplify, filter, and transfer body sounds and three lead electrocardiogram (ECG) waveforms. The CORE 500™ Digital Stethoscope also displays ECG waveforms and heart rate on the display and accompanying mobile application (when prescribed or used under the care of a clinician or by lay users).A lay user is not intended to interpret or take clinical action based on the device output without consulting with a qualified healthcare professional.
2025-10-15
CORE 500 Digital Stethoscope - Ruby Chestpiece - The CORE 500™ Digital Stethoscope is intended to be used by clinicians or lay users to electronically amplify, filter, and transfer body sounds and three lead electrocardiogram (ECG) waveforms. The CORE 500™ Digital Stethoscope also displays ECG waveforms and heart rate on the display and accompanying mobile application (when prescribed or used under the care of a clinician or by lay users).A lay user is not intended to interpret or take clinical action based on the device output without consulting with a qualified healthcare professional.
2025-10-15
CORE 500 Digital Stethoscope FIGS Earpiece - Fight Club Pink - E8
2025-08-12
CORE 500 Digital Stethoscope - Bundle-CHP - E8
2025-08-12
CORE 500 Digital Stethoscope - Bundle-BLK - E8
2025-08-12
CORE 500 Digital Stethoscope - Bundle-SLV - E8
2025-08-12
CORE 500 Digital Stethoscope - Electric Pink Earpiece - E8
2025-08-12
CORE 500 Digital Stethoscope - Electric Pink Chestpiece - E8
2025-08-12
CORE 500 Digital Stethoscope - Ruby Earpiece - E8
2025-03-19
CORE 500 Digital Stethoscope FIGS Earpiece - Seaglass - E8
2025-03-18
CORE 500 Digital Stethoscope FIGS Earpiece - Dark Harbor - E8
2025-03-18
CORE 500 Digital Stethoscope FIGS Earpiece - Winning Red - E8
2025-03-18
CORE 500 Digital Stethoscope FIGS Earpiece - Pink Ribbon - E8
2025-03-18
CORE 500 Digital Stethoscope FIGS Earpiece - Moss - E8
2025-03-18
CORE 500 Digital Stethoscope FIGS Earpiece - Royal Blue - E8
2025-03-18
CORE 500 Digital Stethoscope FIGS Earpiece - Sandstone - E8
2025-03-18
CORE 500 Digital Stethoscope FIGS Earpiece - Mauve - E8
2025-03-18
CORE 500 Digital Stethoscope FIGS Earpiece - Grey - E8
2025-03-18
CORE 500 Digital Stethoscope FIGS Earpiece - Black - E8
2025-03-18
CORE 500 Digital Stethoscope - Amethyst Bundle - E8
2025-03-17
CORE 500 Digital Stethoscope - Sapphire Bundle - E8
2025-03-17
CORE 500 Digital Stethoscope - Wintergreen Bundle - E8
2025-03-17
CORE 500 Digital Stethoscope - Sapphire Chestpiece - E8
2025-03-17
CORE 500 Digital Stethoscope - Wintergreen Chestpiece - E8
2025-03-17
CORE 500 Digital Stethoscope - Sapphire Earpiece - E8
2025-03-17
CORE 500 Digital Stethoscope - Wintergreen Earpiece - E8
2025-03-17
CORE 500 Digital Stethoscope - Amethyst Chestpiece - E8
2025-03-12