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510(k) Data Aggregation

    K Number
    K091369
    Device Name
    ELECTROFLUIDGRAPH
    Manufacturer
    AKERN USA, LLC
    Date Cleared
    2009-10-14

    (159 days)

    Product Code
    MNW
    Regulation Number
    870.2770
    Why did this record match?
    Applicant Name (Manufacturer) :

    AKERN USA, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ElectroFluidGraph™is used to estimate the subject's body composition parameters of Fat Free Mass, Fat Mass, Total Body Water and Extra-Cellular Water; in "generally healthy" subjects of 21 to 87 years old.
    Device Description
    Not Found
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