BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    PROTOCO2L INSUFFLATOR MODEL 6400

    K Number: K013219 · Decision Feb 19, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    23
    Applicant Total
    56
    Review Days
    146

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    Basic Information

    Device Name
    PROTOCO2L INSUFFLATOR MODEL 6400
    K Number
    K013219
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    E-Z-Em, Inc.
    Date Received
    September 26, 2001
    Decision Date
    February 19, 2002
    Product Code
    FCX
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FCX Insufflator, Automatic Carbon-Dioxide For Endoscope

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    Other Clearances by E-Z-Em, Inc.

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    K053008 E-Z-EM ENDOSCOPIC CO2 REGULATOR
    K041178 EMPOWER TRANSFER SET, (CAT. NO. 7725)
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    K974621 PERCUPUMP II WITH EDA
    K961845 PERCUPUMP II WITH EDA
    Search all 56 clearances from E-Z-Em, Inc. →