NHJ — Device, Positive Pressure Breathing, Intermittent Class II

FDA Device Classification

Classification Details

Product Code
NHJ
Device Class
Class II
Regulation Number
868.5905
Submission Type
Review Panel
AN
Medical Specialty
Anesthesiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K242438breas medicalClearoMay 16, 2025
K231728abmrcBiWaze Clear SystemApril 8, 2024
K213564abmrcBiWaze Clear SystemDecember 21, 2022
K200988hill-rom services pteMaximus SystemMay 26, 2020
K191912abmrcBiWaze CoughMarch 27, 2020
K192143hill-rom services pteMaximus SystemFebruary 14, 2020
K151689hill-rom services pteMetaNeb 4 SystemMarch 17, 2016
K140598dima italiaPEGASO COUGH, PEGASO A-COUGH, PEGASO A-COUGH PERCOctober 16, 2014
K140605dima italiaMINIPEGASO COUGH, MINIPEGASO A-COUGH, MINIPEGASO A-COUG PERCOctober 3, 2014
K132988lung assistVITAL COUGHMarch 28, 2014
K124032hill-rom services pteMETANEBApril 25, 2013
K113549seoil pacificCOMFORT COUGHFebruary 21, 2013
K121955respironicsCOUGHASSIST T70 DEVICEDecember 14, 2012
K120277lung assistVITAL COUGHSeptember 12, 2012
K072292dima italiaNEGAVENT PLUS PEGASO COUGH, MODEL: DA-3 PLUSJanuary 7, 2008
K051964comedicaPOWERNEBDecember 1, 2005
K003684vortran medical technology 1PERCUSSIVENEB, MODEL PN-2001February 23, 2001
K002598j. h. emersonEMERSON COUGH ASSIST MODEL CA-3000 W/AUTOMATIC TIMING AND MODEL CM-3000 W/MANUALNovember 22, 2000
K982016vortran medical technology 1PIPER IPPB MODEL 2055November 3, 1998
K981726vortran medical technology 1PERCUSSIVETECH HF, MODEL 2001September 17, 1998