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510(k) Data Aggregation

    K Number
    K093081
    Device Name
    POCKET BVM
    Date Cleared
    2010-02-05

    (127 days)

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

    MICROBVM SYSTEMS LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Pocket BVM Resuscitator is intended for manual pulmonary resuscitation and emergency respiratory support of adult patients.
    Device Description
    The Pocket BVM is a manual emergency ventilator device whose purpose is to manually apply positive pressure to a patient's airways to support ventilation and oxygenation. The Pocket BVM incorporates bags and valve assemblies and is intended to provide emergency respiratory support to a patient through a face mask or a tube inserted into the patient's airway. The Pocket BVM can apply ventilation to a patient either through a mask (supplied with the device) or an artificial airway (not supplied). The Pocket BVM device maintains the functionality of existing devices and also has the advantage of small external dimensions (when packed) and light weight. It can be unpacked and made operational in seconds. The Pocket BVM complies with ISO 10651-4:2002; Particular requirements for operator powered resuscitators.
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