BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    Cellvizio 100 Series Systems with Confocal Miniprobes

    K Number: K171345 · Decision Aug 4, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    44
    Registration Numbers
    44
    Same Product Code
    53
    Applicant Total
    8
    Review Days
    88

    Basic Information

    Device Name
    Cellvizio 100 Series Systems with Confocal Miniprobes
    K Number
    K171345
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mauna Kea Technologies
    Date Received
    May 8, 2017
    Decision Date
    August 4, 2017
    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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