Data / Medical devices / United States / Eko Health, Inc.
Eko Health, Inc.: FDA-registered device maker in Emeryville, CA, United States, 9 510(k) clearances
Eko Health, Inc. is registered with the FDA (registration 3011651230) in Emeryville, CA, United States. It lists 5 device types. The FDA files 9 510(k) clearances under its listings, the newest dated July 23, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011651230
- Address
- 2100 Powell St, Suite 300, Emeryville, CA, United States, 94608
- Owner or operator
- Eko Health, Inc. (10049275)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- August 31, 2015
- Registered through
- 2026
- Brand names listed
- 3M Littmann® CORE Digital Stethoscope, CORE 300 Digital Stethoscope, CORE 500 Digital Stethoscope, Eko Analysis Software, Eko CORE, Eko Electronic Stethoscope System, Eko Foundation Analysis Software with Transformers (EFAST), Eko Low Ejection Fraction Tool (ELEFT) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrocardiograph | DPS | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | 2 | Manufacturer | accessdata.fda.gov |
| Phonocardiograph | DQC | 1 | Manufacturer | accessdata.fda.gov |
| Reduced Ejection Fraction Machine Learning-Based Notification Software | QYE | 2 | Manufacturer | accessdata.fda.gov |
| Stethoscope, Electronic | DQD | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 23, 2026 | K261694 | CORE 300 Digital Stethoscope | DQD | Substantially Equivalent | Eko Health, Inc. | accessdata.fda.gov |
| August 12, 2025 | K251494 | Eko Foundation Analysis Software with Transformers (EFAST) | DQD | Substantially Equivalent | Eko Health, Inc. | accessdata.fda.gov |
| March 28, 2024 | K233609 | CORE 500 Digital Stethoscope | DQD | Substantially Equivalent | Eko Health, Inc. | accessdata.fda.gov |
| March 28, 2024 | K233409 | Eko Low Ejection Fraction Tool (ELEFT) | QYE | Substantially Equivalent | Eko Health, Inc. | accessdata.fda.gov |
| May 26, 2023 | K230111 | CORE 500 Digital Stethoscope | DQD | Substantially Equivalent | Eko Devices, Inc. | accessdata.fda.gov |
| June 29, 2022 | K213794 | Eko Murmur Analysis Software (EMAS) | DQD | Substantially Equivalent | Eko Devices, Inc. | accessdata.fda.gov |
| April 6, 2020 | K200776 | Eko CORE | DQD | Substantially Equivalent | Eko Devices, Inc. | accessdata.fda.gov |
| January 15, 2020 | K192004 | Eko Analysis Software | MWI | Substantially Equivalent | Eko Devices, Inc. | accessdata.fda.gov |
| August 28, 2015 | K151319 | Eko Electronic Stethoscope System | DQD | Substantially Equivalent | Eko Devices, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Stethoscope, Electronic
- All makers of Electrocardiograph
- All makers of Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- All makers of Reduced Ejection Fraction Machine Learning-Based Notification Software
- All makers of Phonocardiograph
Updated July 23, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.