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510(k) Data Aggregation

    K Number
    K234096
    Device Name
    MonoStereo
    Manufacturer
    MedicalTek Co., Ltd.
    Date Cleared
    2024-09-19

    (268 days)

    Product Code
    EOB
    Regulation Number
    874.4760
    Why did this record match?
    Applicant Name (Manufacturer) :

    MedicalTek Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MonoStereo is intended to be used together with 2D monoscopic endoscope systems to provide simulated 3D visualization for observation during ENT diagnostic and therapeutic procedures.
    Device Description
    Not Found
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