BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE

    K Number: K071153 · Decision Jun 11, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    6
    Applicant Total
    30
    Review Days
    47

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    Basic Information

    Device Name
    GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULE
    K Number
    K071153
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Given Imaging , Ltd.
    Date Received
    April 25, 2007
    Decision Date
    June 11, 2007
    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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    Other Clearances by Given Imaging , Ltd.

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    K153466 PillCam COLON 2 Capsule Endoscopy System
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    K103025 GIVEN PILLCAM PLATFORM WITH RAPID 6.5 / GIVEN PILLCAM PLATFORM WITH PILLCAM ESO 3 CAPSULES
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