BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇫🇷 France

    Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System

    K Number: DEN170092 · Decision Nov 2, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    4
    Applicant Total
    2
    Review Days
    315

    Basic Information

    Device Name
    Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System
    K Number
    DEN170092
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    878.4550
    Medical Specialty
    General, Plastic Surgery
    Decision
    Unknown
    Applicant
    Fluoptics
    Date Received
    December 22, 2017
    Decision Date
    November 2, 2018
    Product Code
    QDG
    Advisory Committee
    General, Plastic Surgery
    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
    QDG Parathyroid Autofluorescence Imaging Device

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