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

    ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)

    K Number: K252360 · Decision Mar 28, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    1
    Applicant Total
    6
    Review Days
    242

    Basic Information

    Device Name
    ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)
    K Number
    K252360
    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
    July 29, 2025
    Decision Date
    March 28, 2026
    Product Code
    SAT
    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
    SAT Pulmonary Hypertension Machine Learning-Based Notification Software

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