LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K123359
    Device Name
    OVS1 VIDEO SYSTEM
    Manufacturer
    OLIVE MEDICAL CORP.
    Date Cleared
    2012-12-19

    (49 days)

    Product Code
    FCW, GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    OLIVE MEDICAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OVS 1 Video System is indicated for use in diagnostic and operative endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening. The OVS1 Video System is indicated for use with a compatible Olive Medical Camera Head and other accessory devices including an endoscope, optical coupler, and light cable
    Device Description
    The OVS I Video System is a Camera Control Unit with integrated LED Light Source and Video Display for use in a surgical environment to view endoscopic images when interfaced with the Olive Medical TCK I HD Camera Head, an endoscope, a light cable, and other accessory devices.
    Ask a Question

    Page 1 of 1