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510(k) Data Aggregation

    K Number
    K192713
    Device Name
    Altera Filter and HME/Filter
    Manufacturer
    Meditera Tibbi Malzeme San. ve Tic. A.S.
    Date Cleared
    2020-03-16

    (171 days)

    Product Code
    CAH
    Regulation Number
    868.5260
    Why did this record match?
    Applicant Name (Manufacturer) :

    Meditera Tibbi Malzeme San. ve Tic. A.S.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Filter only - For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and/or expired gases is desired. Use up to 24 hours. HME / Filter - For use with ventilators, anesthesia machines and open flow systems where filtration of inspired and/or expired gases is desired and to maintain moisture levels in the patient's respiratory tract during anesthesia, artificial respiration and other types of assisted ventilation. Use up to 24 hours. Environment of use - clinical setting including hospital, sub-acute, pre-hospital and home For patient with Tidal Volumes > 300 ml.
    Device Description
    The subject device is provided in two (2) configurations. - Filter only ● - . HME / Filter combination - The common features are: - Standard conical 15 mm / 22 mm fittings for connections - Female luer lock port for gas sampling for end-tidal CO2 ●
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    K Number
    K192563
    Device Name
    Altera gas Sampling Lines
    Manufacturer
    Meditera Tibbi Malzeme San. ve Tic. A.S.
    Date Cleared
    2020-01-17

    (122 days)

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

    Meditera Tibbi Malzeme San. ve Tic. A.S.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Altera Gas Sampling Lines are intended to connect from a port in the breathing circuit to the expired gas monitor.
    Device Description
    The Altera Gas Sampling Lines consists of a disposable single patient use coextruded gas sampling line which is provided in 3 different lengths: 2, 2.5, and 3 meters. The disposable single patient use gas sampling lines are smooth narrow diameter tubes that have standardized male luer connectors at both ends. The gas sampling line connects from a port in a circuit to an expired gas monitor. The gas sampling line provides a conduit for drawing gas samples from the sampling port to the gas monitor to analyze respiratory gases. These disposable single patient use gas sampling lines are used to transmit one directional flow of gas sample from the patient breathing circuit port to the gas module host device. A vacuum source and gas measurement sensors are in the host device, which pull the gas from the sampling port to the host device for gas monitoring.
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