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510(k) Data Aggregation

    K Number
    K981157
    Device Name
    STABLE FLOW
    Manufacturer
    CMED
    Date Cleared
    1998-06-16

    (77 days)

    Product Code
    FPA
    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

    A device used to regulate the flow of fluids from a container, such as an I.V. bag, to a patient's vascular system, through a needle or catheter inserted into a vein. For single use.

    Device Description

    Stable Flow, I.V. Flow Controller

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a device named "Stable Flow IV Flow Controller." This document primarily indicates that the device has been found substantially equivalent to a predicate device and is cleared for market. It does not contain a detailed study report or specific acceptance criteria and performance data for the device itself.

    Therefore,Based on the provided document, I cannot fulfill the request as it asks for information (acceptance criteria, study details, sample sizes, ground truth establishment, MRMC studies, etc.) that is not present in the FDA 510(k) clearance letter.

    The letter acknowledges the submission and clarifies the regulatory pathway, but it does not include the technical study details that would typically be found in a study report.

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