Eko Health, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Eko Foundation Analysis Software with Transformers (EFAST), Eko Low Ejection Fraction Tool (ELEFT), CORE 500 Digital Stethoscope
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Eko Health, Inc. Cardiovascular ✕
4 devices
Cleared
Jul 23, 2026
CORE 300 Digital Stethoscope
Cardiovascular
62d
Cleared
Aug 12, 2025
Eko Foundation Analysis Software with Transformers (EFAST)
Cardiovascular
89d
Cleared
Mar 28, 2024
Eko Low Ejection Fraction Tool (ELEFT)
Cardiovascular
174d
Cleared
Mar 28, 2024
CORE 500 Digital Stethoscope
Cardiovascular
136d