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

    90XL INSTRUMENTATION SYSTEM

    K Number: K050812 · Decision May 5, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    12
    Applicant Total
    9
    Review Days
    35

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    Basic Information

    Device Name
    90XL INSTRUMENTATION SYSTEM
    K Number
    K050812
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5820
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Mesa Laboratories, Inc.
    Date Received
    March 31, 2005
    Decision Date
    May 5, 2005
    Product Code
    FIZ
    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
    FIZ Meter, Conductivity, Non-Remote

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