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

    Konan Specular Microscope XVII

    K Number: K191558 · Decision Mar 26, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    8
    Same Product Code
    8
    Applicant Total
    7
    Review Days
    288

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    Basic Information

    Device Name
    Konan Specular Microscope XVII
    K Number
    K191558
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1850
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Konan Medical, Inc.
    Date Received
    June 12, 2019
    Decision Date
    March 26, 2020
    Product Code
    NQE
    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
    NQE Microscope, Specular

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