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510(k) Data Aggregation

    K Number
    K073410
    Device Name
    SAVE RESUSCITATOR
    Date Cleared
    2008-09-12

    (283 days)

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

    ARTIVENT CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SAVe™ Resuscitator is intended for manual pulmonary resuscitation and emergency respiratory support. SAVe Resuscitator is intended for patients with a body mass of more than 15kg (~33 lbs), approx. 3 years of age.
    Device Description
    The SAVe™ Manual Resuscitator is a hand operated resuscitator that provides control of the volume of delivered ventilation gas (air or oxygenenriched gas).
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