Medical Device Manufacturer · US , Emeryville , CA

Eko Health, Inc. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2024
3
Total
3
Cleared
0
Denied

FDA 510(k) cleared devices by Eko Health, Inc. Cardiovascular ✕

3 devices
1-3 of 3
Cleared Aug 12, 2025
Eko Foundation Analysis Software with Transformers (EFAST)
K251494 · DQD
Cardiovascular · 89d
Cleared Mar 28, 2024
Eko Low Ejection Fraction Tool (ELEFT)
K233409 · QYE
Cardiovascular · 174d
Cleared Mar 28, 2024
CORE 500 Digital Stethoscope
K233609 · DQD
Cardiovascular · 136d
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