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

    MiiS Horus Eye Anterior Camera

    K Number: K193188 · Decision Jan 14, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    55
    Same Product Code
    107
    Applicant Total
    7
    Review Days
    57

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    Basic Information

    Device Name
    MiiS Horus Eye Anterior Camera
    K Number
    K193188
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1850
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medimaging Integrated Solution, Inc (Miis)
    Date Received
    November 18, 2019
    Decision Date
    January 14, 2020
    Product Code
    HJO
    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
    HJO Biomicroscope, Slit-Lamp, Ac-Powered

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    Other Clearances by Medimaging Integrated Solution, Inc (Miis)

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    K234113 MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video Box
    K223926 VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box
    K214050 ENT Nasopharyngoscope and Accessories
    K181260 MiiS Horus Scope DPT 100
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