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510(k) Data Aggregation

    K Number
    K002758

    Validate with FDA (Live)

    Device Name
    AGILENT COMPONENT MONITORING SYSTEM, AGILENT CARDIAC OUTPUT MODULE, AGILENT INVASIVE PRESSURE MODULE, MODEL M1175A/76A
    Manufacturer
    AGILENT TECHNOLOGIES DEUTSCHLAND GMBH
    Date Cleared
    2001-02-22

    (170 days)

    Product Code
    DSI
    Regulation Number
    870.1025
    Type
    Traditional
    Panel
    Cardiovascular
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    K013624,K033444
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K003038

    Validate with FDA (Live)

    Device Name
    AGILENT COMPONENT MONITORING SYSTEM, AGILENT V24/26, AGILENT BIS MODULE, MODEL M1175A/76A/77A,REV.L,M1205A,REV.L,M1034A
    Manufacturer
    AGILENT TECHNOLOGIES DEUTSCHLAND GMBH
    Date Cleared
    2000-12-15

    (77 days)

    Product Code
    OLW,OLT,OMC,ORT
    Regulation Number
    882.1400
    Type
    Traditional
    Panel
    Neurology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    K014159
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K001722

    Validate with FDA (Live)

    Device Name
    AGILENT COMPONENT MONITORING SYSTEM; AGILENT INVASIVE BLOOD PRESSURE MODULE
    Manufacturer
    AGILENT TECHNOLOGIES DEUTSCHLAND GMBH
    Date Cleared
    2000-06-30

    (24 days)

    Product Code
    MHX
    Regulation Number
    870.1025
    Type
    Special
    Panel
    Cardiovascular
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    K013199,K013624
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K001333

    Validate with FDA (Live)

    Device Name
    AGILENT COMPONENT MONITORING SYSTEM, AGILENT MULTI-MEASUREMENT SERVER AND COMPACT PORTABLE PATIENT MONITOR, AGILENT NONI
    Manufacturer
    AGILENT TECHNOLOGIES DEUTSCHLAND GMBH
    Date Cleared
    2000-05-17

    (20 days)

    Product Code
    DSI
    Regulation Number
    870.1025
    Type
    Special
    Panel
    Cardiovascular
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    K013199,K013624,K014159,K051366,K052707,K071885,K101600
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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