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510(k) Data Aggregation

    K Number
    K160660
    Device Name
    Medline Waste Station
    Manufacturer
    Medline Industries, Inc.
    Date Cleared
    2017-01-19

    (317 days)

    Product Code
    DQO
    Regulation Number
    870.1200
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Medline Waste Station is intended for syringe fluid administration, and waste collection. The Waste Station is for use during catheterization procedures and fluid delivery and for the temporary storage of waste fluids from invasive radiology, cardiology, and CT lab procedures.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called the "Medline Waste Station." It does not contain information about acceptance criteria, device performance studies, or details regarding AI/algorithm performance. The letter is primarily about regulatory clearance based on substantial equivalence to a predicate device.

    Therefore, I cannot extract the requested information from this document.

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