K250649
- 510(k) number
- K250649
- Device name
- Bunkerhill ECG-EF
- Applicant
- BunkerHill Health CA · US
- Product code
- QYE — Reduced Ejection Fraction Machine Learning-Based Not
- Decision date
- 2025-09-19
- Date received
- 2025-03-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.3 MB · U.S. public domain
Also available from FDA: K250649.pdf
Official FDA record: K250649
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.