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510(k) Data Aggregation

    K Number
    K060082
    Device Name
    TIANJIN MEDIS DISPOSABLE INFUSION SET
    Manufacturer
    TIANJIN MEDIS INTERNATIONAL TRADE CO., LTD.
    Date Cleared
    2006-03-31

    (80 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Type
    Abbreviated
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    TIANJIN MEDIS INTERNATIONAL TRADE CO., LTD.

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

    Tianjin Medis Disposable Infusion set is a device intended to administer fluids from a container to a patient's vascular system through a catheter inserted into a vein.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for a medical device (Tianjin Medis Disposable Infusion Set). It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria, device performance studies, or ground truth establishment.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based on the provided text. The document is primarily a regulatory approval notice, not a performance study report.

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