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510(k) Data Aggregation

    K Number
    K001091
    Device Name
    CARDIOSET (HARDWARE), MODEL HO4; CARDIOSET SCL (SOFTWARE), MODEL V3.01
    Date Cleared
    2000-08-10

    (128 days)

    Product Code
    Regulation Number
    870.2920
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEXT MILLENNIUM SOFTWARE SOLUTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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