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

    EM-4000 Specular Microscope

    K Number: K171313 · Decision Jan 19, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    8
    Same Product Code
    8
    Applicant Total
    5
    Review Days
    260

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    Basic Information

    Device Name
    EM-4000 Specular Microscope
    K Number
    K171313
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1850
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tomey Corporation
    Date Received
    May 4, 2017
    Decision Date
    January 19, 2018
    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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