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

    VS3-IR

    K Number: K183453 · Decision Mar 4, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    60
    Applicant Total
    33
    Review Days
    81

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    Basic Information

    Device Name
    VS3-IR
    K Number
    K183453
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medtronic
    Date Received
    December 13, 2018
    Decision Date
    March 4, 2019
    Product Code
    OWN
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OWN Confocal Optical Imaging

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