BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    MSI MEDSERV INTERNATIONAL-RIGID ENDOSCOPE

    K Number: K083840 · Decision Sep 28, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    17
    Applicant Total
    1
    Review Days
    278

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    Basic Information

    Device Name
    MSI MEDSERV INTERNATIONAL-RIGID ENDOSCOPE
    K Number
    K083840
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Msi Medserv International Deutschland GmbH
    Date Received
    December 24, 2008
    Decision Date
    September 28, 2009
    Product Code
    GCM
    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
    GCM Endoscope, Rigid

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