FDA 510(k) Applications for Medical Device Product Code: NVP (Holding Chambers, Direct Patient Interface)

FDA 510(k) Applications for Medical Device Product Code "NVP"
(Holding Chambers, Direct Patient Interface)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K080100	ACTIVAERO AMERICA, INC.	WATCHHALER	06/30/2008
K101348	AGAPLASTIC IND. COM. LTDA.	AGACHAMBER SPACER	04/29/2011
K140062	FSC LABORATORIES, INC.	FSC ANTI-STATIC VALVED COLLAPSIBLE HOLDING CHAMBER	10/03/2014
K130598	INSPIRX, INC.	INSPIRACHAMBER ANTI-STATIC VALVED HOLDING CHAMBER	06/05/2013
K101136	KOO(SHANGHAI)INDUSTRIES CO., LTD.	FISIO CHAMBER SPACE	01/28/2011
K122252	MEDICAL DEVELOPMENTS INTERNATIONAL	SPACE CHAMBER PLUS COMPACT SPACE CHAMBER PLUS	11/13/2013
K143615	MEDICAL DEVELOPMENTS INTERNATIONAL LIMITED	Antistatic Compact Space Chamber	01/26/2016
K110293	RESPIRONICS NEW JERSEY, INC.	OPTICHAMBER DIAMOND VALVED HOLDING CHAMBER	08/09/2011
K210558	Thayer Medical Corporation	LiteAire Basic Dual-Valved, Collapsible MDI Holding Chamber	04/01/2022
K160109	THAYER MEDICAL CORPORATION	Thayer Medical LiteAire Dual-valved, Collapsible MDI Holding Chamber	05/19/2017
K181649	Trudell Medical International	AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC)	01/11/2019
K070674	TRUDELL MEDICAL INTL.	AEROCHAMBER PLUS ANTI-STATIC VALVED HOLDING CHAMBER WITH FLOW-VU INSPIRATORY FLOW INDICATOR	04/11/2007
K112010	TRUDELL MEDICAL INTL.	AEROCHAMBER PLUS FLOW-VU ANTI-STATIC VALVED HOLDING CHAMBER (VHC)	07/11/2012
K052332	TRUDELL MEDICAL INTL.	AEROCHAMBER Z-STAT PLUS VALVED HOLDING CHAMBER	09/21/2005
K110136	TRUDELL MEDICAL INTL.	RESPICHAMBER VALVED HOLDING CHAMBER	04/18/2011