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510(k) Data Aggregation

    K Number
    K970158
    Device Name
    BABYPAC
    Manufacturer
    PNEUPAC, INC.
    Date Cleared
    1998-04-28

    (467 days)

    Product Code
    CBK, MNT
    Regulation Number
    868.5895
    Why did this record match?
    Applicant Name (Manufacturer) :

    PNEUPAC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The babyPAC pneumatically powered ventilator is specifically designed for use by qualified medical caregivers, paramedics and other trained personnel for patient ventilation during respiratory distress or insufficiency in the rescue, pre-hospital and alternative site arenas.
    Device Description
    Not Found
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