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510(k) Data Aggregation

    K Number
    K001081
    Date Cleared
    2000-06-30

    (87 days)

    Product Code
    Regulation Number
    870.2770
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BIOZ.PC HEMODYNAMIC MONITOR MODEL BZ-500/BZ-501; BIOZ.PC USER SOFTWARE INSTALLATION KIT MODEL BZ-810

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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