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

    CardioTag™

    K Number: K243566 · Decision Jul 22, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    4
    Applicant Total
    2
    Review Days
    246

    Basic Information

    Device Name
    CardioTag™
    K Number
    K243566
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2320
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cardiosense, Inc.
    Date Received
    November 18, 2024
    Decision Date
    July 22, 2025
    Product Code
    DXR
    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
    DXR Ballistocardiograph

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