BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    Withings ECG App

    K Number: K240795 · Decision Jun 15, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    8
    Applicant Total
    7
    Review Days
    450

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    Basic Information

    Device Name
    Withings ECG App
    K Number
    K240795
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2345
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Withings
    Date Received
    March 22, 2024
    Decision Date
    June 15, 2025
    Product Code
    QDA
    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
    QDA Electrocardiograph Software For Over-The-Counter Use

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