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510(k) Data Aggregation

    K Number
    K981307
    Device Name
    INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL RESUSCIATOR
    Manufacturer
    INTERNATIONAL RESPIRATORY SYSTEMS, INC.
    Date Cleared
    1998-07-06

    (87 days)

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

    INTERNATIONAL RESPIRATORY SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The International Respiratory Systems, Inc's Manual Resuscitator is designed to provide The International respence of reversible apnea, commonly associated with cardiopulmonary arrest.
    Device Description
    International Respiratory Systems, Inc.'s Manual Resuscitator
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    K Number
    K981308
    Device Name
    INTERNATIONAL RESPIRATORY SYSTEMS, INC.'S MANUAL PULMONARY RESUSCITATOR WITH RUBBER COMPRESSION BAG
    Manufacturer
    INTERNATIONAL RESPIRATORY SYSTEMS, INC.
    Date Cleared
    1998-07-06

    (87 days)

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

    INTERNATIONAL RESPIRATORY SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The International Respiratory Systems, Inc's Manual Resusciated to provide I he international Respuatory BystonEs, Ino of reasoned as a commonly associated with cardiopulmonary arrest.
    Device Description
    Manual Pulmonary Resuscitator
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    Ask a specific question about this device

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