K232699
- 510(k) number
- K232699
- Device name
- Low Ejection Fraction AI-ECG Algorithm
- Applicant
- Anumana, Inc. MA · US
- Product code
- QYE — Reduced Ejection Fraction Machine Learning-Based Not
- Decision date
- 2023-09-28
- Date received
- 2023-09-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K232699.pdf
Official FDA record: K232699
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.