Eko Core 500 Digital Stethoscope Chestpiece
The Eko CORE 500 chestpiece acquires body sounds and three-lead electrocardiogram signals during a clinician’s physical assessment. Its diaphragm captures sounds, while electrodes arranged…
The Eko CORE 500 chestpiece acquires body sounds and three-lead electrocardiogram signals during a clinician’s physical assessment. Its diaphragm captures sounds, while electrodes arranged around the chestpiece capture the electrical signals. It forms the patient-contact portion of the digital stethoscope system.
The CORE 500 system amplifies and filters the sound signal, with Cardiac, Pulmonary and Wide Band modes for different listening tasks. The chestpiece is used with a detachable earpiece and the Eko application; ECG waveforms and heart rate can be viewed on the device display and application.
Clinical Interpretation
The measurements support clinician evaluation together with other relevant patient information. The chestpiece is a component of the stethoscope system, which is intended for adult and pediatric patients.
Who Else Makes It
Concentrated in Zhejiang (1), Guangdong (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Yahorng Dongguan Electronic Co Ltd | Guangdong | Guangdong | Contract manufacturer | 8 |
| ADC Ningbo Co., Ltd. | Ningbo | Zhejiang | Exporter | 13 |
| Suzhou Melodicare Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
Record
| Listed by | Eko Devices, Inc., United States |
|---|---|
| FDA product code | DQD |
| Device type | Stethoscope, Electronic |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1875 |
| 510(k) | K230111 |
| Record published | 2023-07-10 |
| Record revised | 2024-11-25 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| COR500 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 3M™ Littmann® | 3M Company | 29 |
| Adscope® | American Diagnostic Corp. | 14 |
| Littmann® | 3M Company | 13 |
| RNK Products | Rnk Products, Inc. | 10 |
| Tyto Stethoscope | Tyto Care, Ltd. | 5 |
| Steth IO | Steth IO | 4 |
| Heroic Faith | Heroic Faith International Ltd. | 3 |
| Stethophone Pro | Sparrow Acoustics Inc. | 2 |
| AeviceMD | Aevice Health Pte. Ltd. | 2 |
| Eko Core 500 and CAC500 Founder’s Edition bundle | Eko Devices, Inc. | 1 |
| Eko Core 500 and CAC500 Standard bundle | Eko Devices, Inc. | 1 |
| Stethophone | Sparrow Acoustics Inc. | 1 |
Showing 12 of 79. All products under Stethoscope, Electronic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K230111 | 2023-05-26 |
| K213794 | 2022-06-29 |
| K200776 | 2020-04-06 |
| K170874 | 2017-05-19 |
| K151319 | 2015-08-28 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.