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510(k) Data Aggregation

    K Number
    K955520
    Device Name
    RESCUE BREATHER
    Manufacturer
    INTERNATIONAL SAFETY, INC.
    Date Cleared
    1996-10-08

    (309 days)

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

    INTERNATIONAL SAFETY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Rescue Breather is intended to separate the patient and the rescuer during cardiopulmonary resuscitation (CPR) on adults and children. It is a single use device and is not sold sterile.
    Device Description
    The device is a flat sheet measuring 6" by 11" which has integral ear loops to hold it in position during use. The mask provides separation between the skin, mucous membranes and oral secretions of the patient and the rescuer. There is a one-way valve in the middle of the mask which directs breathing flow to the patient.
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