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510(k) Data Aggregation

    K Number
    K963848
    Device Name
    MANUAL RESUSCITATOR
    Manufacturer
    OWENS-BRIGAM MEDICAL CO.
    Date Cleared
    1997-07-07

    (285 days)

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

    OWENS-BRIGAM MEDICAL CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use for this device is to provide emergency respiratory support for Adult, Child and Infant.
    Device Description
    The device is a disposable, single patient use manual resuscitator that includes a compression bag, intake and patient valve, and a closed vinyl oxygen reservoir bag, (options: open corrugated tubing or open expandable tubing in lieu of closed vinyl oxygen reservoir bag), and an optional peep valve and/or face mask.
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