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510(k) Data Aggregation

    K Number
    K991918
    Manufacturer
    Date Cleared
    1999-10-29

    (144 days)

    Product Code
    Regulation Number
    876.5980
    Reference & Predicate Devices
    N/A
    Predicate For
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Nutrisafe Extension Tube is intended for use with the Nutrisafe Feeding Tube, which incorporates safety luer lock hub connectors, which eliminate the risk of I.V. administration through the feeding tube. The Nutrisafe Extension Tube will allow 150 cm of additional tubing for the clinician to utilize, where necessary.

    Device Description

    Nutrisafe® Extension Tube

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called the "Nutrisafe Extension Tube." It is not a study report and therefore does not contain the information requested regarding acceptance criteria, study details, or performance metrics of a device.

    The letter simply states that the FDA has reviewed the 510(k) notification and determined the device to be substantially equivalent to legally marketed predicate devices. It grants permission to market the device, subject to general controls provisions of the Act.

    Therefore, I cannot provide the requested table or answer the questions based on the provided text. The document is administrative, not a scientific study report.

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