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510(k) Data Aggregation

    K Number
    K020127
    Device Name
    SMARTFLOW PULSE TRANSMISSION COEFFICIENT
    Manufacturer
    FLORENCE MEDICAL LTD.
    Date Cleared
    2002-02-14

    (30 days)

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

    FLORENCE MEDICAL LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SmartFlow® is intended for use in coronary and peripheral vasculature in conjunction with pressure measurement devices during and after diagnostic procedures, such as angiography, or interventional procedures, such as angioplasty, to evaluate the hemodynamic status of the diseased arteries and to provide further clinical information in the diagnosis and treatment of both coronary and peripheral artery diseases.
    Device Description
    The SmartFlow® with the Pulse Transmission Coefficient software is a tool for measuring coronary and peripheral vasculature hemodynamic status patterns during diagnostic and interventional procedures. The SmartFlow® is a PC based system comprising of a full color display with a touchscreen for patient data entry and control, and software calculations of the CFR and FFR parameters. The display and touchscreen are mounted in a shielded metal housing.
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    K Number
    K012947
    Device Name
    SMARTFLOW
    Manufacturer
    FLORENCE MEDICAL LTD.
    Date Cleared
    2001-10-02

    (28 days)

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

    FLORENCE MEDICAL LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Florence Medical Ltd. SmartFlow™ is intended for use in coronary and peripheral vasculature in conjunction with pressure measurement devices during and after diagnostic procedures, such as angiography, or interventional procedures, such as angioplasty, to evaluate the hemodynamic status of the diseased arteries and to provide further clinical information in the diagnosis and treatment of both coronary and peripheral artery diseases.
    Device Description
    The SmartFlow™ with the Multiple Lesion software is a tool for measuring coronary and peripheral vasculature hemodynamic status patterns during diagnostic and interventional procedures. The SmartFlow™ is a PC based system comprising of a full color display with a touchscreen for patient data entry and control, and software calculations of the CFR and FFR parameters. The display and touchscreen are mounted in a shielded metal housing. The SmartFlow™ may be operated through its touchscreen or through an Infrared receiver port which allows the use of a hand-held remote. There are two defined accessories for use with the device: Monitor interface for standard medical monitors and hand-held Infrared remote control which activates function keys and acts as a mouse.
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    K Number
    K003122
    Device Name
    SMARTFLOW, MODEL SFIP 2000
    Manufacturer
    FLORENCE MEDICAL LTD.
    Date Cleared
    2001-05-14

    (221 days)

    Product Code
    DSK
    Regulation Number
    870.1110
    Why did this record match?
    Applicant Name (Manufacturer) :

    FLORENCE MEDICAL LTD.

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