(88 days)
The intended use for the liquid oxygen system is to provide supplementury oxygen at a prescribed flow rate to patients with lung disorders such as COPD (Chronic Obstructive Pulmonary Disease) or other conditions as prescribed by a physician.
Portable Liquid Oxygen System BYJ
The provided document is a 510(k) clearance letter from the FDA for the "Protégé Liquid Oxygen System". This document
DOES NOT CONTAIN
information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. This type of document merely grants market clearance based on substantial equivalence to a predicate device, it does not detail the specifics of performance testing.
Therefore, I cannot fulfill your request using the provided text.
§ 868.5655 Portable liquid oxygen unit.
(a)
Identification. A portable liquid oxygen unit is a portable, thermally insulated container of liquid oxygen that is intended to supplement gases to be inhaled by a patient, is sometimes accompanied by tubing and an oxygen mask. An empty portable liquid oxygen unit is a device, while the oxygen contained therein is a drug.(b)
Classification. Class II (performance standards).