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

    MANOSCAN MOTILITY WITH IMPEDANCE VISUALIZATION SYSTEM

    K Number: K091070 · Decision May 19, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    68
    Applicant Total
    2
    Review Days
    35

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    Basic Information

    Device Name
    MANOSCAN MOTILITY WITH IMPEDANCE VISUALIZATION SYSTEM
    K Number
    K091070
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1725
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sierra Scientific Instruments, Inc.
    Date Received
    April 14, 2009
    Decision Date
    May 19, 2009
    Product Code
    FFX
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    FFX System, Gastrointestinal Motility (Electrical)

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    Other Clearances by Sierra Scientific Instruments, Inc.

    K Number Device Name
    K031169 MOTILITY VISUALIZATION SYSTEM