Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Eko Health, Inc.

FDA 510(k) & PMA Approved Devices — 3 products

Total Devices3
Categories2
Latest Approval2025-08-12
TypeNumberDevice NameCodeDate
510(k) K251494 Eko Foundation Analysis Software with Transformers (EFAST) DQD 2025-08-12 View
510(k) K233609 CORE 500 Digital Stethoscope DQD 2024-03-28 View
510(k) K233409 Eko Low Ejection Fraction Tool (ELEFT) QYE 2024-03-28 View