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510(k) Data Aggregation

    K Number
    K131016
    Device Name
    ROGS
    Date Cleared
    2013-11-27

    (230 days)

    Product Code
    Regulation Number
    868.5440
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    ROGS

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

    Intended to produce oxygen for emergency use at 6 lpm flow rate for at least 15 minutes (90 liters).

    Device Description

    The ROGS is a chemical based portable oxygen generator which generates 99% oxygen for at least 15 minutes at a flow rate of at least 6 lpm. It is a self-contained device with the oxygen delivered via standard oxygen face mask or nasal cannula.

    AI/ML Overview

    The provided text describes the ROGS portable oxygen generator, a chemical-based device intended for emergency oxygen production. The acceptance criteria and the study proving it meets these criteria are outlined through a comparison to a predicate device (Molecular Products - POGS - K062153) and performance testing.

    Here's an organized breakdown of the requested information:

    1. Table of Acceptance Criteria and Reported Device Performance:

    FeatureAcceptance Criteria (Predicate/Proposed Device)Reported Device Performance (ROGS)
    % Oxygen99%>99% generated
    Flow Rate minimum6 lpm> 6 lpm
    Duration of flowAt least 15 minutesAt least 15 minutes
    Total Oxygen generated90 liters (implied from 6 lpm for 15 minutes)At least 90 liters (6 lpm for at least 15 minutes)
    Time to start of gas flow60 seconds (Predicate)5 seconds
    VOC / PM2.5 / OzoneYes (tested)Met and passed criteria; does not generate unwanted particulate matter or undesirable gases
    Environmental testingHigh and low temperature conditionsMet and passed criteria (Storage: -20° to +40°C; Operating: 0° to +40°C)
    Mechanical testingVibrationMet and passed criteria
    External container temperature
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