BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    OtoSight Middle Ear Scope

    K Number: K222655 · Decision Sep 26, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    24

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    Basic Information

    Device Name
    OtoSight Middle Ear Scope
    K Number
    K222655
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    892.1560
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Photonicare, Inc.
    Date Received
    September 2, 2022
    Decision Date
    September 26, 2022
    Product Code
    QJG
    Advisory Committee
    Radiology
    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
    QJG Device System, Imaging, Tympanic Membrane And Middle Ear

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    Other Clearances by Photonicare, Inc.

    K Number Device Name
    K191804 TOMi Scope