Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K222511
    Device Name
    Oxy2Pro
    Manufacturer
    Southmedic Inc.
    Date Cleared
    2023-11-21

    (459 days)

    Product Code
    CCK
    Regulation Number
    868.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Southmedic Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Oxy2Pro is a single patient, disposable procedural mask with access for the insertion of oral scopes, probes, delivery of supplemental oxygen and monitoring breathing by providing a means to sample exhaled CO2. It is for nonintubated, adult patients who are breathing spontaneously.
    Device Description
    The Southmedic Oxy2Pro is designed to have a flexible, thin membrane that is intended to be breached when requiring oral access for scope entry. This slitted membrane is intended to allow the mask to return to a closed- mask functionality after having been used with a scope. This device is to be used in conjunction with FDA cleared capnographs.
    Ask a Question

    Page 1 of 1