BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)

    K Number: K250652 · Decision Jul 28, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    4
    Applicant Total
    6
    Review Days
    146

    Basic Information

    Device Name
    ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)
    K Number
    K250652
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2380
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Anumana, Inc.
    Date Received
    March 4, 2025
    Decision Date
    July 28, 2025
    Product Code
    QYE
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QYE Reduced Ejection Fraction Machine Learning-Based Notification Software

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