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510(k) Data Aggregation

    K Number
    K062119
    Device Name
    HLR MODEL 601 HEART LUNG RESUSCITATOR AND HEARTSAVER 100
    Date Cleared
    2006-09-22

    (59 days)

    Product Code
    Regulation Number
    870.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL PRODUCTS MFG., LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The HLR™ Model-601 Heart Lung Resuscitator and the HeartSaver 100 are intended to be used as adjuncts to manual CPR on patients in cardiac arrest. The HLR Model-601 and the HeartSaver 100 are designed for use on adults or large children and should be administered by trained medical personnel. The HLR™ Model-601 Heart Lung Resuscitator and the HeartSaver 100 are intended for use as adjuncts to manual CPR on patients who are non-breathing, unconscious, pulseless and in urgent need of cardiopulmonary resuscitation.
    Device Description
    HLR Model-601 Heart Lung Resuscitator and the HeartSaver 100 are modifications to the pre-Amendment HLR® PARA-MED™ Heart Lung Resuscitator. The HLR Model-601 and the HeartSaver 100 are compact, totally portable, automatic CPR Devices. The HLR Model-601 and the HeartSaver 100 are air-powered medical devices used for emergency resuscitation of patients who have stopped spontaneous breathing. The HLR Model-601 and the HeartSaver 100 provide automatic chest compressions and ventilation per the current American Heart Association Guidelines. The devices can control the depth of chest compressions and the volume of ventilation. The HLR Model-601 and the HeartSaver 100 allow the trained user three options of compression to ventilation ratios (30:2), (15:2) and continuous chest compressions without ventilation.
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