QFB · Class II · 21 CFR 868.5480

FDA Product Code QFB: Isocapnic Ventilation Device

An Isocapnic Ventilation Device Is A Prescription Device Used To Administer A Blend Of Carbon Dioxide And Oxygen Gases To A Patient To Induce Hyperventilation. This Device May Be Labeled For Use With Breathing Circuits Made Of Reservoir Bags (21 Cfr 868.5320), Oxygen Cannulas (21 Cfr 868.5340), Masks (21 Cfr 868.5550), Valves (21 Cfr 868.5870), Resuscitation Bags (21 Cfr 868.5915), And/or Tubing (21 Cfr 868.5925).

Leading manufacturers include Thornhill Research, Inc..

1
Total
0
Cleared
573d
Avg days
2019
Since

FDA 510(k) Cleared Isocapnic Ventilation Device Devices (Product Code QFB)

1 devices
1–1 of 1
Not Cleared Mar 14, 2019
ClearMate
DEN170044
Thornhill Research, Inc.
Anesthesiology · 573d

About Product Code QFB - Regulatory Context