3B Medical, Inc. has received FDA 510(k) clearance on its new third generation bi-level device, the Luna G3 Auto-BPAP.
3B Medical Receives 510(k) Clearance on new Bi-Level
The Luna G3 Auto BPAP is a modern and technologically advanced Bi-Level PAP therapy device for the treatment of obstructive sleep apnea. This device is available with integrated heated tubing, cellular connectivity and 3B's advanced algorithm which automatically senses and adjusts pressure settings to ensure airway patency for a comfortable night's sleep. The Luna G3 Auto- BPAP provides a backup rate that reduces the work of breathing with pressure settings up to 25 cmH20.
COO Justin Smith said: "We are excited by FDA's recent action approving use of the Lumin G3 Auto-BPAP. The Luna G3 is 3B Medical's third generation platform and incorporates a new design, a smaller footprint, and more advanced functionality. The Luna G3 Auto-BPAP delivers non-invasive ventilatory support with all of the bells and whistles that DME's have come to expect from 3B Medical."