(329 days)
For use by adults in conjunction with portable oxygen supply units to conserve and regulate oxygen supply and consumption. SANPO is not intended for use by neo-natal or pediatric patients.
oxygen conservation device, SANPO, which is intended for use in conjunction with oxygen supply systems to conserve and regulate oxygen supply and consumption.
The provided text is a 510(k) summary for the SANPO oxygen conservation device. While it states the device's intended use and claims substantial equivalence to a predicate device, it does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.
The document is a regulatory approval letter and not a study report. It refers to the device's physical and technical characteristics being compared to the predicate, but it does not detail the specific characteristics compared, the criteria for "substantial similarity," or any empirical data from a study.
Therefore, I cannot fulfill your request for the specific points because the necessary information is not present in the provided text.
§ 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).