Model note · Stethoscope
Eko CORE 500 Digital Stethoscope
The Eko CORE 500 is a digital stethoscope that amplifies and filters heart, lung and other body sounds and records a three lead ECG through dry electrodes on its chestpiece. It is used by clinicians in clinics, wards and telehealth, and since 2024 is also cleared for lay users. It shows waveforms and heart rate on a built in display and streams to the Eko app over Bluetooth Low Energy, where Eko's AI software can flag possible murmurs and arrhythmias.
The model
Maker, model and type.
- Maker
- Eko Health, Inc.
- Model
- CORE 500 Digital Stethoscope
- Device type
- Stethoscope
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Signals acquired | Body sounds and three lead ECG from three dry electrodes | Source |
| Audio frequency response | 20 Hz to 2000 Hz | Source |
| ECG frequency response | 0.1 to 250 Hz | Source |
| Auscultation modes | Cardiac, Pulmonary and Wide Band | Source |
| Heart rate | Derived from the phonocardiogram (PCG based) | Source |
| Connectivity | Bluetooth Low Energy to the Eko mobile app | Source |
| Battery | Rechargeable 3.7 V lithium ion; up to 60 hours of regular clinical use; about 3 hours from empty to full via USB-C | Source |
| Standards | IEC 60601-1, IEC 60601-1-11, IEC 60601-2-47, IEC 60601-1-2, ISO 10993-1, IEC 62366-1 | Source |
| FDA clearance | K233609 (OTC and prescription, 28 March 2024), predicate K230111 (prescription, 26 May 2023); 21 CFR 870.1875, product codes DQD and DPS | Source |
Recalls
Recalls.
This note lists no recalls. Check the FDA recall database for the latest record.
Sources
Where this note comes from.
- FDA 510(k) K233609 summary, CORE 500 Digital Stethoscope
- Eko CORE 500 product page
- Eko support: CORE 500 battery and charging
- Eko support: Hard reboot the CORE 500
- Eko support: CORE 500 firmware update mode
- openFDA MAUDE problem counts, CORE 500
- FDA 510(k) K213794, Eko Murmur Analysis Software
Not covered: The full CORE 500 IFU was not available as readable text, so warnings are limited and amplification and noise cancellation figures (widely marketed as up to 40x with ANC) were not confirmed from an Eko document and are left out. No FDA recalls were found, MAUDE holds only four single reports, and Eko publishes no numbered error codes or service manual.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.