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510(k) Data Aggregation

    K Number
    K210992
    Device Name
    Altech® Exhalation Valve (Single Limb and Dual Limb)
    Manufacturer
    Meditera Tibbi Malzeme San Ve TIC AS
    Date Cleared
    2021-12-23

    (265 days)

    Product Code
    CBP
    Regulation Number
    868.5870
    Why did this record match?
    Applicant Name (Manufacturer) :

    Meditera Tibbi Malzeme San Ve TIC AS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The exhalation valves are intended to be used in ventilator circuits consistent with the indicated use of the ventilator to which they are attached. The single limb model directs flow and allows for pressure monitoring and may be used within hospitals and for home care use. The dual limb model regulates flow and is for use in hospitals and for home care use. The exhalation valve are used with adults, pediatrics, and neonates. The exhalation valves are for single patient use and can be used for a maximum of 30 days.
    Device Description
    The Altech® Exhalation Valves (Single Limb) are available in 2 configurations intended for use in Single and Dual Limb ventilator circuits. The difference between the configurations is location of exhaust of the expired gas to the room. In the Single limb, the valve is integrated to the limb and expired gas exhausts through the opening below the valve whereas in the valve is attached to the end of the exhalation limb and the expired gas exhausts through device end of the valve.
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