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510(k) Data Aggregation

    K Number
    K153628
    Device Name
    ROSC-U Mini Chest Compressor (RMCC)
    Manufacturer
    Resuscitation International, LLC
    Date Cleared
    2016-01-30

    (43 days)

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

    Resuscitation International, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To perform Cardiopulmonary Resuscitation (CPR) on adult patients and only adult patients in cases of clinical death as defined by a lack of spontaneous breathing and pulse.
    Device Description
    The RMCC is an automated, portable chest compressor, which provides continuous chest compressions as an adjunct to performing manual CPR. It is powered by a battery powered Control Unit. The RMCC provides consistent CPR support for cardiac arrest patients under conditions which might otherwise hinder the effectiveness of manual techniques. - 1. Compressor Assembly: contains a motor that drives the compressor pad to depress a patient's chest. - 2. Control Unit: contains the battery, power ON/OFF switch, Function Control Panel and umbilical power cord connecting it to the compressor assembly. Note: The battery charger is a separate unit. - 3. Torso Restraint: is placed underneath and around the back of the patient to firmly secure the compressor assembly to the patient. - 4. Stabilizer: serves a dual purpose; providing a head support and also attaches to the torso restraint to provide stability during continuous operation of the RMCC especially during patient transport.
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    K Number
    K102068
    Device Name
    MINIATURIZE CHEST COMPRESSOR (MCC)
    Manufacturer
    RESUSCITATION INTERNATIONAL
    Date Cleared
    2010-11-16

    (116 days)

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

    RESUSCITATION INTERNATIONAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To perform Cardiopulmonary Resuscitation (CPR) on adult patients and only adult patients in cases of clinical death as defined by a lack of spontaneous breathing and pulse.
    Device Description
    The miniaturized compressor (MCC) is an automated, portable chest compressor, which provides continuous chest compressions as an adjunct to performing manual CPR. It is powered by compressed oxygen or air. The MCC provides consistent CPR support for cardiac arrest patients under conditions, which might otherwise hinder the effectiveness of manual techniques.
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