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510(k) Data Aggregation

    K Number
    K200740
    Device Name
    HD Video Rhino Laryngoscope
    Manufacturer
    KARL STORZ Endoscopy - America, Inc.
    Date Cleared
    2020-08-11

    (141 days)

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

    KARL STORZ Endoscopy - America, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The KARL STORZ CMOS HD Video Rhino-Laryngoscope System is indicated to provide visualization of the nasal lumens and airway anatomy (including nasopharyngeal and trachea) during diagnostic procedures.
    Device Description
    The components subject of this submission are: the Flexible HD Video-Rhino-Laryngoscope (Part Number: 11101 HD), and the IMAGE1 S CCU. The CCU consists of the IMAGE1 S Connect Module (Model Number: TC200US) and IMAGE1 S X-Link (Model Number: TC301US).
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