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

    WISCONSIN DUAL-PHOTON BONE ANALYZER

    K Number: K802180 · Decision Dec 31, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    146
    Applicant Total
    6
    Review Days
    113

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    Basic Information

    Device Name
    WISCONSIN DUAL-PHOTON BONE ANALYZER
    K Number
    K802180
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1170
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Lunar Radiation Corp.
    Date Received
    September 9, 1980
    Decision Date
    December 31, 1980
    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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    Other Clearances by Lunar Radiation Corp.

    K Number Device Name
    K873296 DPX BONE DENSITOMETER
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    K810159 BONE MINERAL ANALYZER CONTROLLER
    K802181 WISCONSIN BONE MINERAL ANALYZER
    K802182 WISCONSIN HEART RATE MONITOR