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

    GIVEN DIAGNOSTIC SYSTEM

    K Number: K052184 · Decision Dec 1, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    6
    Applicant Total
    30
    Review Days
    112

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    Basic Information

    Device Name
    GIVEN DIAGNOSTIC SYSTEM
    K Number
    K052184
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Given Imaging , Ltd.
    Date Received
    August 11, 2005
    Decision Date
    December 1, 2005
    Product Code
    NSI
    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
    NSI System, Imaging, Esophageal, Wireless, Capsule

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