FDA 510(k) Applications for Medical Device Product Code: NHJ (Device, Positive Pressure Breathing, Intermittent)

FDA 510(k) Applications for Medical Device Product Code "NHJ"
(Device, Positive Pressure Breathing, Intermittent)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K213564	ABMRC LLC	BiWaze Clear System	12/21/2022
K191912	ABMRC LLC	BiWaze Cough	03/27/2020
K051964	COMEDICA , INC.	POWERNEB	12/01/2005
K140605	DIMA ITALIA SRL	MINIPEGASO COUGH, MINIPEGASO A-COUGH, MINIPEGASO A-COUG PERC	10/03/2014
K072292	DIMA ITALIA SRL	NEGAVENT PLUS PEGASO COUGH, MODEL: DA-3 PLUS	01/07/2008
K140598	DIMA ITALIA SRL	PEGASO COUGH, PEGASO A-COUGH, PEGASO A-COUGH PERC	10/16/2014
K192143	Hill-Rom Services Pte Ltd	Maximus System	02/14/2020
K200988	Hill-Rom Services Pte Ltd	Maximus System	05/26/2020
K124032	HILL-ROM SERVICES PTE LTD	METANEB	04/25/2013
K151689	Hill-Rom Services Pte Ltd	MetaNeb 4 System	03/17/2016
K002598	J. H. EMERSON CO.	EMERSON COUGH ASSIST MODEL CA-3000 W/AUTOMATIC TIMING AND MODEL CM-3000 W/MANUAL TIMING	11/22/2000
K120277	LUNG ASSIST, INC.	VITAL COUGH	09/12/2012
K132988	LUNG ASSIST, INC.	VITAL COUGH	03/28/2014
K121955	RESPIRONICS, INC.	COUGHASSIST T70 DEVICE	12/14/2012
K113549	SEOIL PACIFIC CORP.	COMFORT COUGH	02/21/2013
K003684	VORTRAN MEDICAL TECHNOLOGY 1, INC.	PERCUSSIVENEB, MODEL PN-2001	02/23/2001
K981726	VORTRAN MEDICAL TECHNOLOGY 1, INC.	PERCUSSIVETECH HF, MODEL 2001	09/17/1998
K982016	VORTRAN MEDICAL TECHNOLOGY 1, INC.	PIPER IPPB MODEL 2055	11/03/1998