BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    VIRTUAL SLIDE SYSTEM, OLYMPUS VS800 SYSTEM

    K Number: K111914 · Decision Aug 21, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    412

    Basic Information

    Device Name
    VIRTUAL SLIDE SYSTEM, OLYMPUS VS800 SYSTEM
    K Number
    K111914
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.1860
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    OLYMPUS AMERICA INC. / SCIENTIFIC EQUIPMENT GROUP
    Date Received
    July 6, 2011
    Decision Date
    August 21, 2012
    Product Code
    OEO
    Advisory Committee
    Hematology
    Review Advisory Committee
    PA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OEO Automated Digital Image Manual Interpretation Microscope

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