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

    SP-1PSpecular Microscope

    K Number: K142417 · Decision May 29, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    8
    Same Product Code
    8
    Applicant Total
    13
    Review Days
    274

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    Basic Information

    Device Name
    SP-1PSpecular Microscope
    K Number
    K142417
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1850
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Topcon Corporation
    Date Received
    August 28, 2014
    Decision Date
    May 29, 2015
    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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