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510(k) Data Aggregation

    K Number
    K980066
    Device Name
    CPR FILTERSHIELD
    Manufacturer
    Date Cleared
    1998-07-16

    (190 days)

    Product Code
    Regulation Number
    868.5915
    Why did this record match?
    Applicant Name (Manufacturer) :

    PLASCO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CPR FILTERSHIELD is a highly portable, single use, physical barrier for use in performing mouth-to mouth resuscitation on adults and children by personnel train in CPR techniques.
    Device Description
    The configuration of this device is a plastic PVC sheet with a hole in the center. Sealed around the hole is two plastic molded supports. An electret fiberous media filter is sealed to the proximal molded support.
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    K Number
    K953414
    Device Name
    CPR MICROMASK WITH OXYGEN INLET
    Manufacturer
    Date Cleared
    1996-03-20

    (244 days)

    Product Code
    Regulation Number
    868.5870
    Why did this record match?
    Applicant Name (Manufacturer) :

    PLASCO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    A device used for mouth-to-mask treatment of respiratory failure.
    Device Description
    The configuration of this pocket-sized device is a cushioned face mask used to enclose the patients nose and mouth. A one-way valve allows the rescuer to provide exhaled air to the patient. The oxygen port will allow oxygen enhancement of the rescuer's exhaled air. Expired air and/or fluids from the patient is vented away from the rescuer due to the one-way valve and an alternate venting route. The device comes in one size and is designed for adults but can be used on infants. By rotating the mask 180 degrees and placing the nose portion just below the infants lover lip, the wider portion of the cushion rests on the forehead. The repositioning of the mask and the soft material of the mask cushion allows for a complete seal of the mask cushion to an infants facial contours. The device is non-sterile. It normally will be packaged in a polybag which may be placed in a zippered nylon pouch. This device is not intended for use by persons not trained in basic life saving skills or those with only a basic bystander course.
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