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

    BREASTVIEW VISUAL MAPPING SYSTEM

    K Number: DEN020001 · Decision Jan 31, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    248

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    Basic Information

    Device Name
    BREASTVIEW VISUAL MAPPING SYSTEM
    K Number
    DEN020001
    Device Class
    FDA class 2
    Clearance Type
    Post-NSE
    Regulation Number
    884.2990
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Unknown
    Applicant
    Assurance Medical
    Date Received
    May 28, 2002
    Decision Date
    January 31, 2003
    Product Code
    NKA
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NKA System, Documentation, Breast Lesion

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