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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
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    TRANSTRACHEAL DEMAND OXYGEN CONTROLLER MODEL DOC-3000

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    To conserve oxygen by delivering flow during the inspiration cycle

    Device Description

    DOC-3000 Demand Oxygen Controller

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the "DOC-3000 Demand Oxygen Controller." This type of document primarily confirms substantial equivalence to a predicate device and outlines regulatory conditions. It does not contain information about acceptance criteria, specific device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.

    Therefore, I cannot provide the information requested in your prompt based on the input document. The document focuses on regulatory approval rather than detailed study results.

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