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510(k) Data Aggregation

    K Number
    K011592
    Device Name
    OXYGEN TREATMENT HOOD
    Date Cleared
    2002-06-19

    (391 days)

    Product Code
    Regulation Number
    868.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMRON INTERNATIONAL DIVING SUPPLY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Amron International Treatment Hood is intended to provide a means to administer gas/oxygen/air to a patient by a clinician in clinical multiplace or monoplace chamber systems.
    Device Description
    The Amron International Oxygen Treatment Hood, Model 8891, was designed for easy use and cost effective operation within a multiplace or monoplace hyperbaric chamber. The hood assembly is placed over a person's head for treating a person with a gas such as oxygen. The assembly includes a reusable neck ring which fits over a user's head, a tubular latex neck seal with one end connected to the neck ring and the other configured to fit around the user's neck, and a transparent hood fastened to a hood ring that can be sealed against the neck ring. Supply and exhaust tubes direct gas into and out the hood through ports located on the neck ring, The supply and exhaust locations allow oxygen to circulate easily throughout the hood increasing performance while reducing noise levels. Supply gas also helps cool the user reducing potential overheating and continuously defogs the hood's optical window.
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