FDA 510(k) K141943, BREATHE TECHNOLOGIES LIFE2000 VENTILATION SYSTEM, by Breathe Technologies

510(K) Number: K141943
Device Name: BREATHE TECHNOLOGIES LIFE2000 VENTILATION SYSTEM
Manufacturer: Breathe Technologies
Device Classification Name: Ventilator, Continuous, Facility Use
Regulation Number: CBK
Classification Product Code: KXA
Date Received: 07/17/2014
Decision Date: 06/12/2015
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology