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

    BODYMETRIX BX2000

    K Number: K082147 · Decision Mar 20, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    233

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    Basic Information

    Device Name
    BODYMETRIX BX2000
    K Number
    K082147
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2770
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Intelametrix, Inc.
    Date Received
    July 30, 2008
    Decision Date
    March 20, 2009
    Product Code
    OMV
    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
    OMV Ultrasonic Body Composition Analyzer