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

    ELECTROFLUIDGRAPH

    K Number: K091369 · Decision Oct 14, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    78
    Applicant Total
    1
    Review Days
    159

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    Basic Information

    Device Name
    ELECTROFLUIDGRAPH
    K Number
    K091369
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2770
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Akern USA, LLC
    Date Received
    May 8, 2009
    Decision Date
    October 14, 2009
    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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