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510(k) Data Aggregation

    K Number
    K053008
    Device Name
    E-Z-EM ENDOSCOPIC CO2 REGULATOR
    Manufacturer
    E-Z-EM, INC.
    Date Cleared
    2005-12-27

    (62 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 :

    E-Z-EM ENDOSCOPIC CO2 REGULATOR

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

    The E-Z-EM ENDOSCOPIC CO2 REGULATOR is designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope.

    The ENDOSCOPIC CO2 REGULATOR allows the physician to modulate and control the CO2 to the patient in an identical manner to that being done currently with room air which is supplied by an air pump in the Light Source of the Endoscopic equipment.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the E-Z-EM Endoscopic CO2 Regulator. It is not a study report and therefore does not contain the information requested in your prompt regarding acceptance criteria, device performance, or details of a study.

    The document primarily states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. It includes the indications for use but no technical specifications or performance data from a study.

    Therefore, I cannot provide the requested table and study details based on the provided text.

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