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

    DUAL-PHOTON TOTAL BODY BONE MINERAL ANA

    K Number: K810140 · Decision Feb 12, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    146
    Applicant Total
    6
    Review Days
    22

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    Basic Information

    Device Name
    DUAL-PHOTON TOTAL BODY BONE MINERAL ANA
    K Number
    K810140
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1170
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Lunar Radiation Corp.
    Date Received
    January 21, 1981
    Decision Date
    February 12, 1981
    Product Code
    KGI
    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
    KGI Densitometer, Bone

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    K802180 WISCONSIN DUAL-PHOTON BONE ANALYZER
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