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510(k) Data Aggregation

    K Number
    K110930
    Device Name
    ACTIVE WASTE GAS SCAVENGER
    Manufacturer
    G. DUNDAS CO.,INC.
    Date Cleared
    2011-06-23

    (80 days)

    Product Code
    CBN
    Regulation Number
    868.5430
    Type
    Special
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ACTIVE WASTE GAS SCAVENGER

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

    The Waste Gas Scavenger is designed for use with vacuum (suction) waste gas disposal systems with anesthesia machines and heart/lung bypass machines.

    Device Description

    Active Waste Gas Scavenger

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called an "Active Waste Gas Scavenger." It is a regulatory document and does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as would be found in a study report.

    Therefore, I cannot provide the requested information based solely on the text provided. This document simply states that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices.

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