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510(k) Data Aggregation

    K Number
    K982943
    Device Name
    TRANSTRACHEAL DEMAND OXYGEN CONTROLLER MODEL DOC-3000
    Manufacturer
    TRANSTRACHEAL SYSTEMS
    Date Cleared
    1999-07-12

    (325 days)

    Product Code
    NFB
    Regulation Number
    868.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRANSTRACHEAL SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To conserve oxygen by delivering flow during the inspiration cycle
    Device Description
    DOC-3000 Demand Oxygen Controller
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    K Number
    K981078
    Device Name
    TRANSTRACHEAL AUGMENTED VENTILATION OXYGEN CONCENTRATOR MODEL NUMBER TTAV 1000
    Manufacturer
    TRANSTRACHEAL SYSTEMS
    Date Cleared
    1998-07-23

    (121 days)

    Product Code
    CAW
    Regulation Number
    868.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRANSTRACHEAL SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    High flow oxygenation for patients requiring supplemental oxygen for the treatment of hypoxemia
    Device Description
    Not Found
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    K Number
    K981080
    Device Name
    SCOOP 1
    Manufacturer
    TRANSTRACHEAL SYSTEMS
    Date Cleared
    1998-06-17

    (85 days)

    Product Code
    BTO
    Regulation Number
    868.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRANSTRACHEAL SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Transtracheal catheter for patients requiring high flow supplemental oxygen for the treatment of hypoxemia
    Device Description
    SCOOP I, Transtracheal Catheter
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    K Number
    K962944
    Device Name
    TRANSTRACHEAL DEMAND OXYGEN CONTROLLER (DOC-2000)
    Manufacturer
    TRANSTRACHEAL SYSTEMS
    Date Cleared
    1996-10-23

    (89 days)

    Product Code
    NFB
    Regulation Number
    868.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRANSTRACHEAL SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - 1) Conserve the flow of oxygen - 2) Deliver oxygen during the inspiration cycle - 3) Maintain adequate oxygen saturation of a patient - 4) Adjustable time for delayed inspiration alarm - 5) Adjustable inspiration time
    Device Description
    Not Found
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