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510(k) Data Aggregation

    K Number
    K041031
    Device Name
    CARDIOSTATION-100 (CS-100)
    Manufacturer
    Date Cleared
    2005-01-26

    (280 days)

    Product Code
    Regulation Number
    870.1425
    Why did this record match?
    Applicant Name (Manufacturer) :

    US CLOVER CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CardioStation-100 is intended to be used as an aid to diagnosis by means of analysis of cardiac electrical signals in the frequency domain, the power spectral estimate.
    Device Description
    Not Found
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