(84 days)
The DeVilbiss SmartLink System can only be used in conjunction with the DV51 and DV54 Series CPAP Systems for follow up of obstructive sleep apnea patients weighing above 30 kg on nasal CPAP therapy.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a medical device called the "DeVilbiss DV5M Smartlink System." This document grants market clearance based on substantial equivalence to a predicate device and does not contain any information about acceptance criteria, device performance, validation studies, sample sizes, ground truth establishment, or expert qualifications.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria, as this information is not present in the provided document.
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§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).