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

    E-Z-FLATE

    K Number: K930581 · Decision Jul 1, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    23
    Applicant Total
    56
    Review Days
    512

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    Basic Information

    Device Name
    E-Z-FLATE
    K Number
    K930581
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    E-Z-Em, Inc.
    Date Received
    February 4, 1993
    Decision Date
    July 1, 1994
    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.

    K Number Device Name
    K071378 MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIES
    K062449 EMPOWERMR INJECTOR SYSTEM, MODEL 9730
    K063029 EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900
    K053008 E-Z-EM ENDOSCOPIC CO2 REGULATOR
    K041178 EMPOWER TRANSFER SET, (CAT. NO. 7725)
    K031571 EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825
    K030854 PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400
    K013219 PROTOCO2L INSUFFLATOR MODEL 6400
    K011160 E-Z EM PERCUPUMP 2001 CT INJECTOR
    K974621 PERCUPUMP II WITH EDA
    Search all 56 clearances from E-Z-Em, Inc. →