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    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    OPTICAL COHERENCE TOMOGRAPHY 3D OCT-2000

    K Number: K092470 · Decision Sep 2, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    30
    Same Product Code
    65
    Applicant Total
    9
    Review Days
    21

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    Basic Information

    Device Name
    OPTICAL COHERENCE TOMOGRAPHY 3D OCT-2000
    K Number
    K092470
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    886.1570
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Topcon Corp.
    Date Received
    August 12, 2009
    Decision Date
    September 2, 2009
    Product Code
    OBO
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OBO Tomography, Optical Coherence

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