LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K190367
    Device Name
    Smith & Nephew Tablet Application
    Manufacturer
    Smith & Nephew
    Date Cleared
    2019-05-21

    (95 days)

    Product Code
    QGY
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    QGY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Smith & Nephew Tablet Application is indicated for wireless control of compatible Smith & Nephew passive surgical and endoscopic devices including camera control unit and patient information system.
    Device Description
    The Tablet Application acts as a tool to remotely capture still and motion pictures, patient file management, and limited redundant control of medical devices. The Tablet Application currently supports the LENS Integrated System and Integration Broker.
    Ask a Question

    Page 1 of 1