BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MY BREAST FRIEND, BREAST SELF-EXAM PAD

    K Number: K023390 · Decision Nov 26, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    48

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    Basic Information

    Device Name
    MY BREAST FRIEND, BREAST SELF-EXAM PAD
    K Number
    K023390
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1940
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mbf Sales, LLC
    Date Received
    October 9, 2002
    Decision Date
    November 26, 2002
    Product Code
    IXH
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IXH Camera, Focal Spot, Radiographic

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