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

    INBODY

    K Number: K130777 · Decision Nov 25, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    78
    Applicant Total
    9
    Review Days
    249

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    Basic Information

    Device Name
    INBODY
    K Number
    K130777
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2770
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biospace Corporation Limited
    Date Received
    March 21, 2013
    Decision Date
    November 25, 2013
    Product Code
    MNW
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MNW Analyzer, Body Composition

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