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    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Fundus Camera

    K Number: K190954 · Decision Jan 22, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    66
    Same Product Code
    155
    Applicant Total
    1
    Review Days
    286

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    Basic Information

    Device Name
    Fundus Camera
    K Number
    K190954
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1120
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Chongqing Bio Newvision Medical Equipment , Ltd.
    Date Received
    April 11, 2019
    Decision Date
    January 22, 2020
    Product Code
    HKI
    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
    HKI Camera, Ophthalmic, Ac-Powered

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