FDA 510(k) Applications for Medical Device Product Code: ONZ (Mechanical Ventilator)

FDA 510(k) Applications for Medical Device Product Code "ONZ"
(Mechanical Ventilator)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K131562	BREATHE TECHNOLOGIES	BREATHE NIOV VENTILATION SYSTEM	03/06/2014
K082982	BREATHE TECHNOLOGIES, INC.	BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES	07/20/2009
K102525	BREATHE TECHNOLOGIES, INC.	BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S)	12/02/2010
K103345	BREATHE TECHNOLOGIES, INC.	BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S)	02/11/2011
K100528	BREATHE TECHNOLOGIES, INC.	BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BT-V2S	04/23/2010
K152664	New Aera, Inc.	TAV System	12/02/2016