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510(k) Data Aggregation

    K Number
    K972134
    Device Name
    BAG DECANTER
    Manufacturer
    REMINGTON MEDICAL, INC.
    Date Cleared
    1997-08-26

    (81 days)

    Product Code
    LHI
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Remington Medical Bag Decanter is used for the aseptic decanting of fluids from flexible containers. The decanter is a sterile, disposable device.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets any criteria.

    The document is a US FDA 510(k) clearance letter for the "Bag Decanter" device, indicating that the device is substantially equivalent to legally marketed predicate devices. This letter does not contain details about specific performance acceptance criteria or study results demonstrating such performance.

    Therefore, I cannot provide the requested information, including the table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set information.

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