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    K Number
    K142012
    Device Name
    FARRELL VALVE SYSTEM WITH EQUILIBRIUM TECHNOLOGY AND ENFIT ENTERAL CONNECTORS
    Manufacturer
    CORPAK MEDSYSTEMS
    Date Cleared
    2014-11-20

    (119 days)

    Product Code
    PIF
    Regulation Number
    876.5980
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    FARRELL VALVE SYSTEM WITH EQUILIBRIUM TECHNOLOGY AND ENFIT ENTERAL CONNECTORS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The FARRELL® Valve System with EQUILIBRIUM TECHNOLOGY™ and ENFit™ Enteral Connectors is a closed reservoir system intended to allow the evacuation of excess gas (gastric distention/bloating) and drainage/collection of enteral feeding formula and gastrointestinal tract contents from patients utilizing an enteral device. The FARRELL® Valve System with EQUILIBRIUM TECHNOLOGY™ and ENFit™ Enteral Connectors is for use with neonates, pediatric, and adult patients.

    Device Description

    Not Found

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for the FARRELL® Valve System with EQUILIBRIUM TECHNOLOGY™ and ENFit™ Enteral Connectors. It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter confirms that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed.

    Therefore, I cannot provide the requested information based on the provided text. The document focuses on regulatory clearance, not detailed performance study data.

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