K251494
- 510(k) number
- K251494
- Device name
- Eko Foundation Analysis Software with Transformers (EFAST)
- Applicant
- Eko Health, Inc. CA · US
- Product code
- DQD — Stethoscope, Electronic
- Decision date
- 2025-08-12
- Date received
- 2025-05-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K251494.pdf
Official FDA record: K251494
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.