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510(k) Data Aggregation

    K Number
    K971066
    Device Name
    TAMARYN I.V. FLOW REGULATOR EXTENSION SET
    Manufacturer
    TAMARYN MEDICAL SYSTEMS, INC.
    Date Cleared
    1997-06-04

    (72 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

    The Tamaryn I.V. Flow Regulator Extension Set is used to control the flow rate of administration infusion fluids to a patient during a gravity intravenous infusion.

    Device Description

    Tamaryn I.V. Flow Regulator Extension Set

    AI/ML Overview

    I am sorry, but based on the provided FDA letter for K971066, a submission for the "Tamaryn I.V. Flow Regulator Extension Set," I cannot provide the detailed information requested regarding acceptance criteria and study data.

    This document is a 510(k) clearance letter, which indicates substantial equivalence to a predicate device. It does not contain the detailed study data, acceptance criteria, or performance metrics that would be part of a submission dossier. The letter confirms that the device can be marketed but does not elaborate on the specific tests or their results.

    Therefore, I cannot populate the table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. This information would typically be found in the 510(k) summary or the full submission, which is not provided here.

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