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Eko Health, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
3
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K251494Eko Foundation Analysis Software with Transformers (EFAST)August 12, 2025
K233609CORE 500 Digital StethoscopeMarch 28, 2024
K233409Eko Low Ejection Fraction Tool (ELEFT)March 28, 2024