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510(k) Data Aggregation

    K Number
    K012177
    Device Name
    VENTVIEW, MODEL 8414095
    Manufacturer
    DRAGER MEDIZINTECHNIK GMBH
    Date Cleared
    2001-09-04

    (54 days)

    Product Code
    CBK
    Regulation Number
    868.5895
    Type
    Special
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VENTVIEW, MODEL 8414095

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    VentView - a PC programm for displaying ventilation parameters and status messages in both graphical and numerical form for the Drager ventilators Savina, Evita 2 dura and Evita 4.

    Device Description

    VentView - a PC programm for displaying ventilation parameters and status messages in both graphical and numerical form for the Drager ventilators Savina, Evita 2 dura and Evita 4.

    AI/ML Overview

    I am sorry, but the provided text only contains an FDA 510(k) clearance letter for the "VentView" device. This letter indicates that the device has received marketing clearance but does not include information about acceptance criteria, specific studies, or performance data to answer your request.

    To provide that information, I would need a different document, such as a summary of safety and effectiveness, a clinical study report, or a detailed technical specification for the VentView device.

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