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510(k) Data Aggregation

    K Number
    K143310
    Device Name
    MoisturemeterD
    Manufacturer
    DELFIN TECHNOLOGIES LTD.
    Date Cleared
    2015-11-19

    (366 days)

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

    DELFIN TECHNOLOGIES LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Delfin MoistureMeterD is a device utilizing inter-arm ratios of tissue dielectric constant (TDC) that supports local assessment of tissue water differences between affected and contralateral non-affected arm tissues to aid in forming a clinical judgment of unilateral lymphedema in women. The device is not intended to make diagnosis or predict arm lymphedema.
    Device Description
    The Delfin MoistureMeterD is a high-frequency bioelectrical analyzer used to detect tissue fluid. The device accurately measures voltage, current and the phase shift of the reflected current of the attenuated electric field and calculate capacitance and. moreover the tissue dielectric constant (TDC). The tissue dielectric constant (TDC) supports the measurement of local tissue fluid.
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