BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video Box

    K Number: K234113 · Decision May 1, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    238
    Applicant Total
    7
    Review Days
    126

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    Basic Information

    Device Name
    MiiS Horus Bronchoscope; MiiS Horus Endoscope Display System -Tablet; MiiS Horus Endoscope Display System -Video Box
    K Number
    K234113
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4680
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medimaging Integrated Solution, Inc (Miis)
    Date Received
    December 27, 2023
    Decision Date
    May 1, 2024
    Product Code
    EOQ
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EOQ Bronchoscope (Flexible Or Rigid)

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    Other Clearances by Medimaging Integrated Solution, Inc (Miis)

    K Number Device Name
    K253217 MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)
    K223926 VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box
    K214050 ENT Nasopharyngoscope and Accessories
    K193188 MiiS Horus Eye Anterior Camera
    K181260 MiiS Horus Scope DPT 100
    K170470 Digital Eye Anterior Camera