FDA 510(k) Applications for Medical Device Product Code: MXA (System,Test,Breath Nitric Oxide)

FDA 510(k) Applications for Medical Device Product Code "MXA"
(System,Test,Breath Nitric Oxide)

FDA 510(k) Number	Applicant	Device Name	Decision Date
DEN030001	AEROCRINE AB	NIOX ARTICLE NO: 02-1000	04/30/2003
K072816	AEROCRINE AB	NIOX MINO	03/03/2008
K101034	AEROCRINE AB	NIOX MINO MODEL 09-1000	09/02/2010
K123683	AEROCRINE AB	NIOX PANEL FOR USE WITH THE NIOX MINO AIRWAY INFLAMMATION MONITOR	12/27/2012
K133898	AEROCRINE AB	NIOX VERO AIRWAY INFLAMMATION MONITOR	11/06/2014
K150233	AEROCRINE AB	NIOX VERO Airway Inflammation Monitor	02/26/2015
K083617	APIERON, INC.	APIERON INSIGHT ENO SYSTEM	01/27/2009
K073265	APIERON, INC.	APIERON INSIGHT EXHALED NITRIC OXIDE (ENO) SYSTEM	03/14/2008
K203695	Bedfont Scientific Ltd	NObreath«	12/17/2021
K213611	CAIRE Diagnostics Inc.	Fenom Pro	06/07/2023
K170983	Circassia AB	NIOX VERO	11/22/2017
K182874	Spirosure, Inc.	Fenom Pro Nitric Oxide Test	02/13/2019