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510(k) Data Aggregation

    K Number
    K962783
    Device Name
    EDEMA SYSTEM
    Manufacturer
    Date Cleared
    1997-10-23

    (463 days)

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

    BIOANALOGICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Edema System is a device intended to provide information which the physician or health care professional can utilize for therapeutic and preventative instruction in treating edema of the extremities. The Edema System is a device intended to provide information which the physician or health care professional can utilize for therapeutic and preventative instruction in treating increased extremity edema.
    Device Description
    The Edema System is a device that measures body composition in terms of edema of the extremities. Specialized software monitors the impedance values taken from the patient along with additional biological data. The device is connected to the patient via non-invasive electrode sensors and placement leads. The device operates off of a 9-volt battery and is fully portable. The addition of an IBM compatible computer workstation is required to run the accompanying software program.
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