LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K133983
    Device Name
    INTRA. OX HANDHELD TISSUE OXIMETER
    Manufacturer
    VIOPTIX INC.
    Date Cleared
    2014-09-12

    (259 days)

    Product Code
    MUD
    Regulation Number
    870.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    VIOPTIX INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Intra.Ox™ Handheld Tissue Oximeter is intended to non-invasively estimate the percent oxygen saturation (StO2) in a volume of tissue. The Intra.Ox™ Handheld Tissue Oximeter is indicated for use in monitoring patients during circulatory or perfusion examinations.
    Device Description
    The ViOptix Intra.Ox™ Handheld Tissue Oximeter is a sterile, cordless, batterypowered device that non-invasively estimates the percent oxygen saturation (StO2) in a volume of tissue. The device uses spatially-resolved optical measurements at four wavelengths. The device performs measurements on the patient by direct physical contact to the patient's tissue and displays the StO2 estimate on the built-in screen. The ViOptix Intra.Ox™ Handheld Tissue Oximeter is a single-use disposable constructed from biocompatible materials that can tolerate bodily fluids and other liquids such as disinfectants and marking materials.
    Ask a Question

    Page 1 of 1