SGR · Class II · 21 CFR 868.5895

FDA Product Code SGR: Noninvasive Positive Airway Pressure System, Facility Use

To Mechanically Assist Patient Breathing By Delivering A Predetermined Percentage Of Oxygen In The Breathing Gas Through Noninvasive Continuous Positive Airway Pressure.

Leading manufacturers include Fisher &Paykel Healthcare , Ltd..

1
Total
1
Cleared
260d
Avg days
2025
Since

List of Noninvasive Positive Airway Pressure System, Facility Use devices cleared through 510(k)

1 devices
1–1 of 1

How to use this database

This page lists all FDA 510(k) submissions for Noninvasive Positive Airway Pressure System, Facility Use devices (product code SGR). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Anesthesiology FDA review panel. Browse all Anesthesiology devices →