BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    ManoScan System

    K Number: K151086 · Decision Apr 28, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    68
    Applicant Total
    30
    Review Days
    372

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    Basic Information

    Device Name
    ManoScan System
    K Number
    K151086
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1725
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Given Imaging , Ltd.
    Date Received
    April 22, 2015
    Decision Date
    April 28, 2016
    Product Code
    FFX
    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
    FFX System, Gastrointestinal Motility (Electrical)

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