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510(k) Data Aggregation

    K Number
    K053168
    Device Name
    BIPAP FOCUS
    Manufacturer
    RESPIRONICS (IRELAND) LIMITED
    Date Cleared
    2006-01-04

    (51 days)

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

    RESPIRONICS (IRELAND) LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BiPAP Focus ventilator is a non-invasive, pressure support ventilator used to augment the breathing of patients suffering from acute or chronic respiratory insufficiency, or respiratory failure, or to maintain airway patency and provide ventilatory support to patients who experience obstructive sleep apnea. It is not intended to provide the total ventilatory requirements of the patient.
    Device Description
    The BiPAP Focus is a non-invasive ventilator which has two (2) ventilation modes: - Continuous positive airway pressure (CPAP) which provides a single level of positive pressure to the patient - Spontaneous/Timed (S/T) which provides two levels of positive pressure (one during inspiration - IpAp and one during expiration - EvAp) and delivers timed breaths if the patient does not initiate a breath.
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