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510(k) Data Aggregation

    K Number
    K240401
    Device Name
    ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US)
    Manufacturer
    OriGyn Medical Technology (Hangzhou) Co., Ltd.
    Date Cleared
    2024-07-26

    (168 days)

    Product Code
    HIH
    Regulation Number
    884.1690
    Type
    Traditional
    Panel
    Obstetrics and Gynecology (OB)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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