SGR

2 FDA 510(k) clearances · Product code

FDA profile

Official device name

Noninvasive Positive Airway Pressure System, Facility Use

Device class

Class II (moderate risk)

Regulation

21 CFR 868.5895

Medical specialty

Anesthesiology

FDA definition

To mechanically assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas through noninvasive continuous positive airway pressure.

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