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510(k) Data Aggregation

    K Number
    K982020
    Device Name
    METRON QA-IDS I.V. PUMP TESTER
    Manufacturer
    METRON U.S., INC.
    Date Cleared
    1998-09-30

    (113 days)

    Product Code
    FRN
    Regulation Number
    880.5725
    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 Metron QA-IDS Infusion Pump Tester is designed for use by trained service technicians, for testing all types of infusion purips. Tests include volumetric tests, and occlusion tests. The Metron-QA-IDS Infusion:Putmp;Tester is designed to be used by trained service technicians.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a device called "Metron QA-IDS I.V. Pump Tester." It does not contain the kind of detailed study information (acceptance criteria, performance data, sample sizes, ground truth, etc.) that you are asking for. It's a regulatory approval document confirming that the device is substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot extract the requested information from the provided text. The document is for a medical device that tests infusion pumps, not an AI or diagnostic device that would typically have the kind of performance metrics you've listed.

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