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510(k) Data Aggregation
K Number
K053168Device Name
BIPAP FOCUS
Manufacturer
RESPIRONICS (IRELAND) LIMITED
Date Cleared
2006-01-04
(51 days)
Product Code
MNS
Regulation Number
868.5895Why 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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