BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    AUDIBLE PRESSURE RELEASE VALVE WITH HUMIDIFIER ADAPTER / AND OXYGEN NIPPLE

    K Number: K111191 · Decision Jul 28, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    69
    Registration Numbers
    69
    Same Product Code
    102
    Applicant Total
    2
    Review Days
    91

    Basic Information

    Device Name
    AUDIBLE PRESSURE RELEASE VALVE WITH HUMIDIFIER ADAPTER / AND OXYGEN NIPPLE
    K Number
    K111191
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.5870
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    WET NOSE TECHNOLOGIES, LLC
    Date Received
    April 28, 2011
    Decision Date
    July 28, 2011
    Product Code
    CBP
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    CBP Valve, Non-Rebreathing

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (CBP), ordered by most recent decision date.

    QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    F&P Optiflow Flow Diverter

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Altech® Exhalation Valve (Single Limb and Dual Limb)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CPR Face Shield

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    OJR215 Pressure Relief Manifold

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology
    View all

    Other Clearances by WET NOSE TECHNOLOGIES, LLC

    K Number Device Name
    K091538 PRESSURE RELEASE VALVE W/AUDIBLE, MODEL PRV 20/40/60; WITH T6 ADAPTER, MODEL PRV 120/140/160; T6 ADAPTER, MODEL T6-100