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510(k) Data Aggregation

    K Number
    K020333
    Device Name
    ATRION MEDICAL QL FLUID DISPENSING SYRINGE
    Manufacturer
    ATRION MEDICAL PRODUCTS, INC.
    Date Cleared
    2002-04-25

    (84 days)

    Product Code
    DXT
    Regulation Number
    870.1650
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K972964,K973230
    Why did this record match?
    Device Name :

    ATRION MEDICAL QL FLUID DISPENSING SYRINGE

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

    The syringe is intended for single use by healthcare professionals to dispense fluids to the body and monitor the pressure of those fluids.

    Device Description

    The Atrion Medical QL™ Fluid Dispensing Syringe consists of a plastic syringe with a screw-type plunger and a locking lever and rotating palm grip that control the plunger, a manometer to measure pressure and a connecting tube.

    AI/ML Overview

    The provided documents discuss the Atrion Medical QL™ Fluid Dispensing Syringe, a medical device. There is no information in these documents about any AI/ML components or studies related to acceptance criteria for such components. The submission is a traditional 510(k) for a physical medical device.

    Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details, as these concepts are not applicable to the content provided.

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