SGR

Noninvasive Positive Airway Pressure System, Facility Use

Product code

SGR

Device name

Noninvasive Positive Airway Pressure System, Facility Use

Device class

Class 2

21 CFR

21 CFR 868.5895

Medical specialty

Anesthesiology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

2

FDA classification definition

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

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2026-01-06.

2 summaries are archived here for direct download.