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

    FRANTZ MEDICAL ELECTRODE

    K Number: K863508 · Decision Feb 6, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    4
    Applicant Total
    5
    Review Days
    150

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    Basic Information

    Device Name
    FRANTZ MEDICAL ELECTRODE
    K Number
    K863508
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2320
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Frantz Medical Development, Ltd.
    Date Received
    September 9, 1986
    Decision Date
    February 6, 1987
    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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