Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K200609
    Device Name
    ENTity WiFi Video Nasopharyngoscope System
    Manufacturer
    Optim, LLC
    Date Cleared
    2021-01-13

    (310 days)

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

    Optim, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ENTity WiFi Video Nasopharyngoscope System is intended to be used for oral or nasal introduction for the examination of the upper airway from the nasal passage to the vocal cords.
    Device Description
    The ENTity WiFi Video Nasopharyngoscope System is a complete video nasopharyngoscopy system that includes a rechargeable, battery-powered, flexible videoscope with an integral LED light source and WiFi connectivity; a video processor box that receives WiFi signals from the videoscope and provides HDMI output to a video monitor; image management and user interface software; a battery charger accessory for the videoscope; and an active touchscreen monitor accessory that can be used to view images and/or to communicate with the software user interface. Light generated by the LED light source located in the videoscope handle is transmitted through glass fiber optic bundles to the distal tip of the scope, where it illuminates the anatomy to be examined. A CMOS image sensor (camera chip) located at the distal tip of the videoscope captures still or video images in the form of electrical signals, which are wirelessly transmitted to the ENTity WiFi Video Processor. The video processor incorporates user interface and image management software. Still and/or video images may be viewed on the ENTity WiFi Active Touchscreen Monitor; the touchscreen features on the monitor can also be used to interact with the ENTity WiFi Video Processor.
    Ask a Question
    K Number
    K130489
    Device Name
    ELECTRODE, FLEXIBLE SUCTION COAGULATOR
    Manufacturer
    OPTIM, LLC.
    Date Cleared
    2013-04-19

    (53 days)

    Product Code
    FEH
    Regulation Number
    876.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    OPTIM, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PRECISION Endoscopic Infrared Coagulator with single-use disposable MAXiguide flexible light guide is intended for treatment of hemorrhoids and other lesions in the colon and rectum by the transmission of infrared energy when used as an accessory to a colonoscope, flexible sigmoidoscope, or other flexible gastrointestinal endoscope.
    Device Description
    This device is designed to coagulate blood and tissue, specifically for treatment of hemorrhoids and small lesions in the colon and rectum, when used as an accessory to a flexible endoscope.
    Ask a Question

    Page 1 of 1