Eko CORE 500™ Digital Stethoscope
US$ 479 Price in USD — free shipping included
Independent profile. MedikalDevice is not affiliated with its manufacturer. Specifications come from public manufacturer documentation — confirm FDA status for your intended use. How we verify profiles.
An electronic stethoscope that amplifies and filters heart, lung and body sounds and records a 3-lead ECG through integrated electrodes. Marketed to clinicians across primary care, cardiology, emergency and virtual care.
Key facts
| Product | CORE 500 Digital Stethoscope |
|---|---|
| Manufacturer | Eko Health, Inc. (formerly Eko Devices) |
| Intended users | Healthcare professionals |
| US FDA status | 510(k) cleared — K230111 |
| Market status | Available |
Main features
- 3-lead ECG with heart rate and rhythm strip on a full-color display
- Up to 40x sound amplification
- Active noise cancellation; cardiac, pulmonary and wide-band filter modes
- Rechargeable battery, up to 60 hours of use; USB-C charging
- Launched June 2023
Connectivity
Bluetooth to the Eko App (recording, sharing, Eko Live Stream).
AI and analysis software
Eko SENSORA platform (FDA-cleared): detection of atrial fibrillation and normal sinus rhythm from ECG, structural heart murmurs, and low ejection fraction (<=40%, cleared April 2024); also heart rate and QRS duration. Requires clinician review.
Software outputs are an aid to the clinician, not a diagnosis, and are limited to the indications cleared for each feature.
Regulatory status in the United States
FDA 510(k) clearance: K230111. Stethoscope hardware cleared May 2023; updated clearance K233609 (Mar 2024). AI algorithms cleared under separate 510(k)s.
Related guide: Stethoscope AI Built-In.
Sources
- ekohealth.com (manufacturer)
- accessdata.fda.gov
- accessdata.fda.gov
- prnewswire.com
- support.ekohealth.com
- ekohealth.com
Profile verified against public sources in October 2026. Trademarks belong to their owners.
