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510(k) Data Aggregation

    K Number
    K120566
    Device Name
    O2PAK OXYGEN GENERATOR
    Manufacturer
    PACIFIC PRECISION PRODUCTS
    Date Cleared
    2012-07-24

    (148 days)

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

    PACIFIC PRECISION PRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The O2PAK™ Portable Oxygen Generator, Model P26029 is intended to provide oxygen for emergency use; the O2PAK™ is currently offered to be used under the Direction of trained medical military personnel in support for disaster relief, crisis response, wartime operations, deterrence and contingency operations, humanitarian relief situations or peacetime engagements.
    Device Description
    The O2PAK™ is designed to be compact, lightweight, portable, durable and easy to carry for emergency use. O2PAK™ Model P26029 is the only O2PAK™ model currently available. Its principle of operation is the same as standard chemical oxygen generators. Oxygen is administered to the patient through a nasal cannula or an equivalent device.
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