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510(k) Data Aggregation

    K Number
    K013219
    Device Name
    PROTOCO2L INSUFFLATOR MODEL 6400
    Manufacturer
    E-Z-EM, INC.
    Date Cleared
    2002-02-19

    (146 days)

    Product Code
    FCX
    Regulation Number
    876.1500
    Type
    Abbreviated
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PROTOCO2L INSUFFLATOR MODEL 6400

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

    The E-Z-EM PROTOCO₂L COLON Insufflator administers and regulates carbon dioxide (CC)) as a convention The E-Z-EM PROTOCOL COLON Insultiator administers and regaller one of the research and conventional Colonoscopy.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the E-Z-EM PROTOCO2L COLON Insufflator, dated February 19, 2002. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter primarily states the substantial equivalence determination for the device.

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