FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K072163 |
3A HEALTH CARE S.R.L. |
HAPPYNEB II, HAPPYNEB III, SPEEDY, NEBBY PLUS AND MYNEB, MODEL 5 |
03/06/2008 |
K063449 |
ACCESS POINT MEDICAL, L.L.C. |
DELUXE NEBULIZER |
03/01/2007 |
K090730 |
ACTIVAERO AMERICA, INC. |
AKITA JET |
11/13/2009 |
K072019 |
ACTIVAERO AMERICA, INC. |
AKITA2 APIXNEB |
11/05/2007 |
K181405 |
Adherium (NZ) Ltd |
Hailie Sensor |
12/10/2018 |
K182573 |
Adherium (NZ) Ltd |
Hailie Sensor |
06/07/2019 |
K182638 |
Adherium (NZ) Ltd |
Hailie Sensor |
06/19/2019 |
K220622 |
Adherium (NZ) Ltd |
Hailie Sensor NF0106 |
07/15/2022 |
K221994 |
Adherium (NZ) Ltd |
Hailie Sensor NF0107 & NF0108 |
10/04/2022 |
K211233 |
Adherium (NZ) Ltd |
Hailie Sensor NF0109 |
08/18/2021 |
K222247 |
Adherium (NZ) Ltd |
Hailie Sensor NF0110 |
02/08/2023 |
K180407 |
Adherium (NZ) Ltd |
Smartinhaler |
07/25/2018 |
K163485 |
Adherium (NZ) Ltd |
SmartTouch |
08/30/2017 |
K173310 |
Adherium (NZ) Ltd |
SmartTouch |
03/26/2018 |
K081650 |
AEROGEN (IRELAND) LTD |
AERONEB GO NEBULIZER |
10/23/2008 |
K070642 |
AEROGEN (IRELAND) LTD |
AERONEB PROFESSIONAL NEBULIZER SYSTEM |
05/07/2007 |
K102240 |
AEROGEN IRELAND, LTD. |
NIVO NEBULIZER SYSTEM |
11/10/2010 |
K143719 |
Aerogen Limited |
Aeroneb USB Contoller System |
07/10/2015 |
K120939 |
AEROGEN LTD |
AERONEB PRO |
04/26/2012 |
K133360 |
AEROGEN LTD |
AERONEB SOLO; AERONEB SOLO ADAPTER |
10/17/2014 |
K103635 |
AEROGEN LTD |
CONTINUOUS NEBULIZATION TUBE SET (CNTS) TUBING: AG-AS3075 + SYRINGE: AG-AS3085; CONTINOUS NEBULIZATION TUBE SET (CNTS) S |
05/13/2011 |
K032849 |
AEROGEN, INC. |
AERONEB GO NEBULIZER, MODEL AG-AG2000 |
11/21/2003 |
K992831 |
AEROGEN, INC. |
AERONEB II, MODEL APN 200 |
08/25/2000 |
K003022 |
AEROGEN, INC. |
AERONEB PORTABLE NEBULIZER |
10/13/2000 |
K021175 |
AEROGEN, INC. |
AERONEB PROFESSIONAL NEBULIZER SYSTEM, MODEL#AG-AP6000 |
05/15/2002 |
K984085 |
AEROMAX TECHNOLOGIES, INC. |
RITEFLO SPACER |
08/05/1999 |
K053360 |
AEROVECTRX CORPORATION |
AEROLIFE ULTRASONIC NEBULIZER, MODEL P2C |
03/23/2006 |
K201167 |
AireHealth Inc. |
AireHealth NebulizerTM |
12/03/2020 |
K983002 |
AIRSEP CORP. |
MYSTIQUE ULTRASONIC NEBULIZER |
10/16/1998 |
K023602 |
ALLEGIANCE HEALTHCARE CORPORATION |
SMALL VOLUME NEBULIZER |
05/01/2003 |
K051260 |
ALLIED HEALTHCARE PRODUCTS, INC. |
SCHUCO MIST AND SCHUCO DELUXE MIST |
09/15/2005 |
K982722 |
AMBU, INC. |
AMBU MEDIBAG ADULT, AMBU MEDIBAG INFANT/CHILD |
04/12/1999 |
K063716 |
AMICI, INC. |
AEROSOL SYSTEM |
12/28/2007 |
K952910 |
AMICI, INC. |
THE SWIRLER NEBULIZER |
03/19/1997 |
K070411 |
AMSINO INTERNATIONAL, INC. |
AMSURE NEBULIZER |
10/01/2007 |
K050104 |
APEX MEDICAL CORP. |
APEX MEDICAL MININEB & MINIPLUS |
02/16/2005 |
K070990 |
APEX MEDICAL CORP. |
APEX MEDICAL MOBINEB, 9R-027 SERIES |
05/18/2007 |
K990435 |
APEX MEDICAL CORP. |
BESTNEB PORTABLE AEROSOL THERAPY UNIT, AP-100100 |
06/05/2000 |
K111246 |
ARMSTRONG MEDICAL LTD. |
SPIRALE DRUG DELIVERY SYSTEM |
08/10/2012 |
K102719 |
ATLANTEAN CORPORATION |
ATLANTEAN TRIGGER NEBULIZER |
07/01/2011 |
K955104 |
AUTOMATIC LIQUID PACKAGING, INC. |
HIGH FLOW ADJUSTABLE ENTRAINMENT NEBULIZER |
06/11/1996 |
K980407 |
B & B MEDICAL TECHNOLOGIES, INC. |
HOPE NEBULIZER |
05/27/1998 |
K030396 |
B & B MEDICAL TECHNOLOGIES, INC. |
OMNI~NEB; OMNI~MAX |
05/07/2004 |
K962161 |
BAXTER HEALTHCARE CORP. |
BAXTER NEBULIZER CAP MODEL 2D0868 |
08/15/1996 |
K091272 |
BESMED HEALTH BUSINESS CORP. |
BESMED JET NEBULIZER BOTTLE SET |
11/10/2009 |
K150591 |
BESMED HEALTH BUSINESS CORP. |
Besmed Reusable Jet Nebulizer |
06/30/2015 |
K031982 |
BIRDSONG MEDICAL DEVICES INC |
BIRDSONG LEVERHALER, MODEL LH-1000 |
04/02/2004 |
K983736 |
BRASAMERICA MEDICAL EQUIPMENT, INC. |
ICEL EVOLUSONIC PORTABLE ULTRASONIC NEBULIZER |
11/10/1998 |
K972371 |
BRASAMERICA MEDICAL EQUIPMENT, INC. |
ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AIR AND PU 12300 AIR |
08/19/1997 |
K203155 |
BreatheSuite Inc |
BreatheSuite MDI V1 |
09/17/2021 |
K982043 |
BREMED ITALIA, S.R.L. |
BRENEB |
11/09/1998 |
K970542 |
BREMED ITALIA, S.R.L. |
MASTER NEB II |
06/24/1997 |
K974379 |
BREMED ITALIA, S.R.L. |
ULTRANEB |
02/18/1998 |
K041418 |
Cardinal Health |
AIRLIFE MISTY FINITY LARGE VOLUME CONTINUOUS NEBULIZER |
06/10/2004 |
K072119 |
Cardinal Health |
AIRLIFE NEBULIZER CAP |
08/10/2007 |
K123527 |
CAREFUSION |
AIRLIFE |
04/25/2013 |
K153748 |
CareFusion |
AirLife Misty Finity Nebulizer |
05/17/2017 |
K062952 |
CHOICE SMART HEALTH CARE CO. LTD. |
C300 SERIES AIR NEBULIZER COMPRESSOR |
02/21/2007 |
K010680 |
CLINICAL TECHNOLOGIES, INC. |
CT SPACER |
05/23/2001 |
K183586 |
Cognita Labs, LLC |
CapMedic |
09/13/2019 |
K000543 |
CONTEMPORARY PRODUCTS, INC. |
CONTEMPRO-MIST |
06/16/2000 |
K964994 |
CONTEMPORARY PRODUCTS, INC. |
CPI MODEL 6240 50 PSI NEBULIZER COMPRESSOR |
02/21/1997 |
K162041 |
Convexity Scientific LLC |
Airworks Nebulizer pe1200m |
05/02/2017 |
K962874 |
CURTIN & ASSOCIATES INTERNATIONAL , INC. |
RESPIFLO/S |
02/25/1997 |
K970289 |
DEVILBISS HEALTH CARE, INC. |
COMPRESSOR/NEBULIZER #3650 |
04/15/1997 |
K952249 |
DEVILBISS HEALTH CARE, INC. |
JET NEBULIZER |
01/30/1996 |
K972778 |
DEY LABORATORIES, INC. |
DEY VIAL SODIUM CHLORIDE 3% |
10/08/1997 |
K961973 |
DHD DIEMOLDING HEALTHCARE DIV. |
DHD ACE WITH MASK KIT |
08/15/1996 |
K973532 |
DHD DIEMOLDING HEALTHCARE DIV. |
STEALTH, METERED DOSE INHALER (MDI) SPACER WITHOUT INTEGRAL ACTUATOR |
03/19/1998 |
K981167 |
DHD HEALTHCARE CORP. |
STEALTH PILOT KIT/ STEALTH SPACER/FACE MASK KIT |
06/18/1998 |
K040718 |
DHD HEALTHCARE CORP. |
TRUST |
04/02/2004 |
K090307 |
DIAGNOSTIC DEVICES, INC. |
DDI ULTRASONIC NEBULIZER SYSTEM |
06/18/2009 |
K133105 |
DIGIO2 INTERNATIONAL CO., LTD |
BREEZE NEBULIZER (NBR-10X) |
06/24/2014 |
K123030 |
DONGGUAN AIDISY MACHINERY & ELECTRONIC EQUIPMENT C |
COMPRESSOR NEBULIZER MODEL MCN-S600XX |
12/19/2013 |
K043238 |
EMG TECHNOLOGY CO., LTD. |
COMPRESSOR NEBULIZER, MODEL EMG NBA02-XXX SERIES |
07/06/2005 |
K052438 |
EMG TECHNOLOGY CO., LTD. |
EMG HANDLE NEBULIZER NB02 SERIES |
01/31/2006 |
K030374 |
EVIT LABS, INC. |
SONIK LDI 20 AIR |
08/25/2003 |
K192971 |
Excellentcare Medical (Huizhou) Ltd. |
Nebulizer Kit |
07/08/2021 |
K182906 |
FeelLife Health Inc. |
Portable Mesh Nebulizer |
09/27/2020 |
K993199 |
FERRARIS MEDICAL, INC. |
POCKET CHAMBER VALVED AEROSOL HOLDING CHAMBER |
03/28/2000 |
K992038 |
FERRARIS MEDICAL, INC. |
POCKETSPACER |
09/09/1999 |
K211560 |
Fisher & Paykel Healthcare Limited |
Airvo Nebulizer Adapter |
12/10/2021 |
K062014 |
FLAEM NUOVA S.P.A. |
FAMILIES OF MASTER NEB, PRIMO NEB, SC03, NEB AID, 4.2.NEB, Q03, FJ03, AND WALKIE-NEB |
03/22/2007 |
K062484 |
FLAEM NUOVA S.P.A. |
FLAEM NUOVA RF6 BASIC AND RF6 PLUS NEBULIZERS |
06/08/2007 |
K970010 |
FLUID PROPULSION TECHNOLOGIES, INC. |
FPT NEBULIZER |
04/01/1997 |
K101552 |
FOSHAN CARE MEDICAL TECHNOLOGY CO., LTD. |
FOSHAN CARE MEDICAL NEBULIZER MODEL KYWH2001 |
03/14/2011 |
K132247 |
FOSHAN GAUNYING ELECTRONICS CO., LTD. |
ULTRASONIC MESH NEBULIZER |
01/08/2014 |
K140211 |
FOSHAN GAUNYING ELECTRONICS CO., LTD. |
ULTRASONIC MESH NEBULIZER |
05/30/2014 |
K121154 |
FOSHAN GAUNYING ELECTRONICS CO., LTD. |
ULTRASONIC NEBULIZER |
08/20/2012 |
K021742 |
GALEMED CORP. |
GALEMED NEB-EASY NEBULIZER |
10/25/2002 |
K952326 |
GLOBAL MEDICAL ENT., INC. |
PULMOMIST |
02/27/1996 |
K192633 |
Globalcare Medical Technology Co., Ltd. |
GUS831 Compressor Nebulizer |
05/01/2020 |
K970035 |
GRAHAM-FIELD, INC. |
JOHN BUNN NEB-U-LITE II MEDICATION COMPRESSOR WITH DISPOSABLE NEBULIZER, MODEL #JBO-112-009 |
04/01/1997 |
K041079 |
GUAN HONG ENTERPRISE CO., LTD. |
GUAN HONG ULTRASONIC NEBULIZER, MODEL DR-103/AC-103 |
09/28/2004 |
K202171 |
HCMed Innovations Co., Ltd. |
Pulmogine Vibrating Mesh Nebulizer |
07/01/2021 |
K121770 |
HEADSTAR MEDICAL PRODUCTS CO., LTD |
HEADSTAR MEDICAL SMALL VOLUME JET NEBULIZER |
04/17/2013 |
K081738 |
HEALTH & LIFE CO., LTD. |
ULTRASONIC NEBULIZER SYSTEM, MODEL HL100 |
09/17/2008 |
K963793 |
HEALTHCARE PRODUCTS, INC. |
OPTIVENT |
04/16/1997 |
K960397 |
HEALTHLINE MEDICAL |
MEDICATOR AEROSOL DRUG DELIVERY SYSTEM |
04/26/1996 |
K962822 |
HEALTHSCAN PRODUCTS, INC. |
OPTICHAMBER |
10/17/1996 |
K963917 |
HOLDEN WALKER CORP. |
HOLDEN-WALKER HUMIDIFIER-NEBULIZER KIT |
02/25/1997 |
K974056 |
HOLOPACK INTERNATIONAL, LP |
0.9.% SODIUM CHLORIDE INHALATION SOLUTION, USP |
01/21/1998 |
K972466 |
HOLOPACK INTERNATIONAL, LP |
SODIUM CHLORIDE INHALATION SOLUTION, USP |
08/28/1997 |
K972467 |
HOLOPACK INTERNATIONAL, LP |
STERILE WATER FOR INHALATION, USP |
08/28/1997 |
K070948 |
HSINER |
HSINER NEBULIZER BOTTLE |
04/25/2007 |
K052811 |
HSINER CO., LTD. |
HSINER JET NEBULIZER, MODEL HS-31100 |
12/21/2005 |
K082009 |
HSINER CO., LTD. |
HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS |
08/22/2008 |
K994352 |
HUDSON RESPIRATORY CARE, INC. |
SIDE DRAFT NEB-U-MIST NEBULIZER, MODEL 41896 |
03/22/2000 |
K042546 |
INFAMED LTD. |
FUNHALER, MODEL FH 101 |
01/03/2005 |
K072822 |
INFAMED LTD. |
FUNHALER, MODEL V-201E |
11/26/2007 |
K991725 |
INSPIRED MEDICAL PRODUCTS LTD. |
SIDESTREAM NEBULIZER |
07/30/1999 |
K991355 |
INSTRUMENTATION INDUSTRIES, INC. |
METERED DOSE INHALER ADAPTER-DISPOSABLE, ADAPTER REUSABLE |
01/27/2000 |
K981249 |
INSTRUMENTATION INDUSTRIES, INC. |
METERED DOSE INHALER-REUSABLE MODEL NUMBER RTC 21-A, METERED DOSE INHALER-DISPOSABLE MODEL NUBER RTC 21-D |
11/23/1998 |
K162753 |
INSTRUMENTATION INDUSTRIES, INC. |
RTC 26-C Inline Aerosol Adapter |
02/28/2017 |
K091111 |
INSTRUMENTATION INDUSTRIES, INC. |
RTC METERED DOSE INHALER ADAPTERS-SINGLE PATIENT USE, MODEL RTC 24-V, RTC MDI ADAPTER KIT-SINGLE PATIENT USE, MODEL RTC |
12/02/2009 |
K101857 |
INSTRUMENTATION INDUSTRIES, INC. |
RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-V |
07/22/2010 |
K992643 |
INVACARE CORP. |
MODEL IRC 1001 AEROSOL COMPRESSOR |
10/27/1999 |
K973468 |
INVACARE CORP. |
MODEL IRC 1199 SCOUT NEBULIZER |
12/08/1997 |
K042483 |
INVACARE CORPORATION |
INVACARE PRO, COMPACT AND PORTABLE DESKTOP |
01/06/2005 |
K051365 |
K-JUMP HEALTH CO., LTD. |
COMPRESSOR NEBULIZER SYSTEM, MODEL KN-9321 |
07/22/2005 |
K121520 |
K-JUMP HEALTH CO., LTD. |
ULTRASONIC NEBULIZER (MESH TYPE) |
03/15/2013 |
K083256 |
K-JUMP HEALTH CO., LTD. |
ULTRASONIC NEBULIZER SYSTEM, MODEL KN-9210 |
06/26/2009 |
K112041 |
KOO(SHANGHAI)INDUSTRIES CO., LTD. |
KOO SMALL VOLUME NEBULIZER (SVN) |
12/22/2011 |
K062811 |
LIFE OUTCOMES, INC. |
DPILOG, MODEL DPC-512 |
12/20/2006 |
K990506 |
MABIS HEALTHCARE, INC. |
MABIS NB-02 ULTRASONIC NEBULIZER |
03/11/1999 |
K041327 |
MED2000 S.R.L. |
MED2000 SPA NEBULIZER ANDYFLOW, MODEL A1/C WITH ACCESSORIES |
07/20/2004 |
K031908 |
MED2000 S.R.L. |
MED2000 SPA NEBULIZER COMPRESSORS, MODELS P1 AND P2, WITH NEBULIZER, AND MED2000 SPA NEBULIZER, MODEL A1/C (ANDYFLOW) |
01/14/2004 |
K072494 |
MEDEL S.P.A. |
AG-CLASSIC |
02/12/2008 |
K063103 |
MEDEL S.P.A. |
AG-EDGE, MODEL 91200 |
01/08/2007 |
K060404 |
MEDEL S.P.A. |
AG-PLUS, MODEL 91210 |
06/22/2006 |
K082541 |
MEDI NUCLEAR CORP., INC. |
HEALTHLINE MEDICATOR / REDINEB AEROSOL DRUG DELIVERY SYSTEM |
11/26/2008 |
K080969 |
MEDI NUCLEAR CORP., INC. |
HEALTHLINE REDI-NEB MEDICATION NEBULIZER, MODEL RN-510 |
07/25/2008 |
K080657 |
MEDI NUCLEAR CORP., INC. |
NEB-90 LARGE VOLUME MEDICATION NEBULIZER |
06/30/2008 |
K981772 |
MEDIC-AID LTD. |
HALOLITE AAD SYSTEM |
11/03/1998 |
K991685 |
MEDIC-AID LTD. |
HALOLITE AAD SYSTEM WITH DEDICATED COMPRESSOR |
08/13/1999 |
K971933 |
MEDIC-AID LTD. |
PORT-NEB |
08/01/1997 |
K970844 |
MEDICAL CONSULTING SERVICE, INC. |
ATOMISOR |
11/13/1997 |
K003344 |
MEDICAL DEPOT, INC. |
MEDICAL DEPOT NEBULIZER, MODEL POWER NEB 2 |
03/15/2001 |
K012006 |
MEDICAL DEPOT, INC. |
MEDICAL DEPOT POWER NEB 1 |
07/13/2001 |
K964078 |
MEDICAL INDUSTRIES AMERICA, INC. |
3050 SPORT-NEB |
01/10/1997 |
K032170 |
MEDICAL INDUSTRIES AMERICA, INC. |
TRANSNEB COMPRESSOR W/NEBULIZER, MODEL 5000 |
05/28/2004 |
K002153 |
MEDISANA USA, INC. |
ULTRASONIC NEBULIZER, MODEL NE-520 |
03/13/2001 |
K220955 |
Medline Industires, Inc. |
Hudson RCI Variable concentration Large Volume Nebulizer (1770) |
06/23/2023 |
K223100 |
Medline Industries, Inc |
Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14) |
06/27/2023 |
K970344 |
MEDTRAK TECHNOLOGIES, INC. |
MDILOG, MODEL MDC-511 |
08/06/1997 |
K990185 |
MEDTRAK TECHNOLOGIES, INC. |
MDILOG, MODEL MDC-512 |
04/01/1999 |
K053490 |
MERITS HEALTH PRODUCTS CO., LTD. |
MERITS HEALTH PRODUCTS PORTABLE NEBULIZER |
07/24/2006 |
K092859 |
MERITS HEALTH PRODUCTS CO., LTD. |
MERITS MODEL N SERIES NEBULIZER COMPRESSORS |
07/02/2010 |
K180871 |
MicroBase Technology Corporation |
Portable Nebulizer |
09/14/2018 |
K170916 |
MicroBase Technology Corporation |
Portable Nebulizer |
11/28/2017 |
K142541 |
MicroVaper Devices |
POCKET NEB |
01/22/2016 |
K012939 |
MONAGHAN MEDICAL CORP. |
AEROVENT II CHC COLLAPSIBLE HOLDING CHAMBER |
09/28/2001 |
K110273 |
MONAGHAN MEDICAL CORPORATION |
AEROVENT PLUS CHC |
06/09/2011 |
K220145 |
Monaghan Medical Corporation |
Monaghan medical filtered mouthpiece kit |
08/24/2023 |
K971808 |
MONARCH MEDICAL |
SPACE CHAMBER FOR MODEL NUMBER AND ACCESSORIES |
09/26/1997 |
K020357 |
NELLCOR PURITAN BENNETT, INC. |
800 SERIES EASYNEB NEBULIZER |
08/07/2002 |
K113033 |
NEPHRON PHARMACEUTICALS CORP. |
SODIUM CHLORDE INHALATION SOLUTION, 0.9% USP-3ML |
06/19/2012 |
K120051 |
NEPHRON PHARMACEUTICALS CORP. |
SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4ML |
04/20/2012 |
K041082 |
NEWPORT MEDICAL INSTRUMENTS, INC. |
NEWPORT NEBSONIC N550 ULTRASONIC NEBULIZER |
09/07/2004 |
K133951 |
NEXUS6, LTD. |
SMARTTOUCH |
04/25/2014 |
K091803 |
NEXUS6, LTD. |
SMARTTRACK SYSTEM |
10/09/2009 |
K040439 |
NORTH AMERICAN TECHNICAL SERVICES (NATS) CORP. |
MDI TRIGGER GUARD |
07/08/2004 |
K082878 |
NSR COMERCIO E REPRESENTACOES LTDA |
NEVONI CLASSIC, MODEL 6600-PO |
12/30/2008 |
K223367 |
Ochsner Clinic Foundation |
Ochsner Connected Inhaler Sensor |
08/30/2023 |
K112564 |
ODYSSEY MEDICAL TECHNOLOGIES |
QUIXIE NEBULIZER |
11/23/2011 |
K141140 |
OMRON HEALTHCARE, INC. |
COMP A-I-R |
09/30/2014 |
K110860 |
OMRON HEALTHCARE, INC. |
COMP A-I-R |
09/02/2011 |
K060811 |
OMRON HEALTHCARE, INC. |
OMRON COMPRESSOR SYSTEMS, MODELS NE-C28,NE-C30 |
05/25/2006 |
K062263 |
OMRON HEALTHCARE, INC. |
OMRON MICRO-AIR VIBRATING MESH NEBULIZER, MODEL NE-U22 |
02/23/2007 |
K960854 |
PACESETTER, INC. |
SIEMENS SERVO ULTRA NEBULIZER 345 |
12/23/1996 |
K963924 |
PARI HOLDING CO. |
LC STAR REUSABLE NEBULIZER 22F50 AND LC STAR DISPOSABLE NEBULIZER 22F70 |
12/10/1996 |
K962072 |
PARI HOLDING CO. |
PRONEB TURBO COMPRESSOR MODEL 38V0200 |
08/21/1996 |
K960675 |
PARI HOLDING CO. |
WALKHALER PORTABLE COMPRESSOR MODEL 45F70 |
05/17/1996 |
K033833 |
PARI INNOVATIVE MANUFACTURERS, INC. |
EFLOW ELECTRONIC INHALER/NEBULIZER |
05/05/2004 |
K070498 |
PARI INNOVATIVE MANUFACTURERS, INC. |
HYPER SAL |
04/26/2007 |
K060399 |
PARI INNOVATIVE MANUFACTURERS, INC. |
LC SPRINT NEBULIZER |
03/02/2006 |
K062158 |
PARI INNOVATIVE MANUFACTURERS, INC. |
LC SPRINT STAR |
08/28/2006 |
K061381 |
PARI INNOVATIVE MANUFACTURERS, INC. |
LC STAR WITH NASAL ADAPTER |
06/02/2006 |
K072670 |
PARI INNOVATIVE MANUFACTURERS, INC. |
MODIFICATION TO: EFLOW ELECTRONIC INHALER/NEBULIZER |
12/13/2007 |
K060357 |
PARI INNOVATIVE MANUFACTURERS, INC. |
TREK S NEBULIZER COMPRESSOR |
04/05/2006 |
K020944 |
PARI INNOVATIVE MANUFACTURERS, INC. |
VORTEX VALVED HOLDING CHAMBER |
05/09/2002 |
K100380 |
PARI RESPIRATORY EQUIPMENT, INC. |
ALTERA NEBULIZER SYSTEM, MODEL 678G1002 |
02/22/2010 |
K223840 |
PARI Respiratory Equipment, Inc. |
eRapid Nebulizer System |
08/11/2023 |
K112859 |
PARI RESPIRATORY EQUIPMENT, INC. |
ERAPID NEBULIZER SYSTEM |
05/30/2012 |
K092560 |
PARI RESPIRATORY EQUIPMENT, INC. |
PARI SINUS |
05/06/2010 |
K092918 |
PARI RESPIRATORY EQUIPMENT, INC. |
PARI VIOS |
02/04/2010 |
K191270 |
PARI Respiratory Equipment, Inc. |
Proneb Max |
01/23/2020 |
K162785 |
PARI Respiratory Equipment, Inc. |
Velox Nebulizer System |
04/14/2017 |
K122857 |
PEGASUS RESEARCH CORP. |
HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-3100 |
11/07/2012 |
K962534 |
PEGASUS RESEARCH CORP. |
THERA-MIST NEBULIZER MODEL-P3000 |
02/28/1997 |
K101424 |
PHARMACARIBE |
PHARMACARIBE INHALED SALINE SOLUTIONS |
08/17/2010 |
K130091 |
PHARMACARIBE |
PULMOSAL |
03/13/2013 |
K982408 |
PIPER MEDICAL PRODUCTS |
AEROTEE, MODEL # 1001 |
09/14/1998 |
K990384 |
PIPER MEDICAL PRODUCTS |
EZFLOW CONTINUOUS NEBULIZER,MODEL 1005 |
04/26/1999 |
K993558 |
PIPER MEDICAL PRODUCTS |
EZFLOW MAX, MODEL 1007 |
11/12/1999 |
K042991 |
PROFILE THERAPEUTICS PLC |
I-NEB AAD SYSTEM |
09/23/2005 |
K052941 |
PROFILE THERAPEUTICS PLC |
I-NEB INSIGHT AAD SYSTEM |
12/09/2005 |
K030747 |
PROFILE THERAPEUTICS PLC |
PRODOSE AAD SYSTEM |
04/22/2004 |
K980074 |
PROJECT MARKETING |
56 SERIES AEROSOL GENERATOR |
06/12/1998 |
K021443 |
PROJECT MARKETING |
56 SERIES JET NEBULIZER |
10/21/2002 |
K060497 |
PROMEDIC, INC. |
BABYAIR |
07/11/2006 |
K060842 |
PROMEDIC, INC. |
REVJET TURBO |
06/21/2006 |
K990897 |
PURITAN-BENNETT IRELAND, LTD. |
NELLCOR PURITAN BENNETT 700 SERIES VENTILATOR SYSTEM, AND EASYNEB NEBULIZER |
03/15/2000 |
K171549 |
Qingdao Future Medical Technology Co., Ltd. |
Intelligent Mesh Nebulizer |
08/31/2018 |
K112824 |
QUALITY LIFE TECHNOLOGIES CO;LTD |
QUALITY LIFE TECHNOLOGIES COMPRESSOR NEBULIZER |
06/21/2012 |
K143671 |
Reciprocal Labs |
Propeller Model 2014-D Sensor |
06/19/2015 |
K152482 |
RECIPROCAL LABS |
Propeller Sensor Model 2014-R |
03/04/2016 |
K152882 |
RECIPROCAL LABS |
Propeller System |
03/08/2016 |
K142960 |
Reciprocal Labs |
Propeller System 2014-R |
03/05/2015 |
K121609 |
RECIPROCAL LABS CORPORATION |
ASTHMAPOLIS SYSTEM |
07/02/2012 |
K180770 |
Reciprocal Labs Corporation |
Propeller Sensor for Neohaler |
08/01/2018 |
K192724 |
Reciprocal Labs Corporation |
Propeller Sensor for Symbicort |
03/26/2020 |
K161454 |
Reciprocal Labs Corporation |
Propeller Sensor Model 2015-E |
11/01/2016 |
K142516 |
RECIPROCAL LABS CORPORATION |
Propeller System |
05/15/2015 |
K140638 |
RECIPROCAL LABS CORPORATION |
PROPELLER SYSTEM - MODEL 2 |
05/02/2014 |
K051284 |
RESPIRICS, INC. |
MD TURBO |
06/22/2005 |
K032809 |
RESPIRONICS HEALTHSCAN, INC. |
HOSPITAL SPACER |
11/13/2003 |
K062689 |
RESPIRONICS LTD. |
SIDESTREAM PLUS |
02/16/2007 |
K042655 |
RESPIRONICS NEW JERSEY, INC. |
INSPIRATION ELITE NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS456 |
10/13/2004 |
K100285 |
RESPIRONICS NEW JERSEY, INC. |
LITETOUCH MASK |
06/29/2010 |
K053203 |
RESPIRONICS NEW JERSEY, INC. |
MYNEB NEBULIZER, MODEL RDD100 |
12/20/2005 |
K072418 |
RESPIRONICS NEW JERSEY, INC. |
OPTICHAMBER ADVANTAGE ANTI-STATIC VALVED HOLDING CHAMBER |
09/12/2007 |
K102454 |
RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD. |
I-NEB AAD SYSTEM WITH TIM; I-NEB INSIGHT AAD SYSTEM |
10/25/2011 |
K170853 |
Respironics Respiratory Drug Delivery (UK) Ltd. |
InnoSpire Go |
11/02/2017 |
K130379 |
ROLLINS MEDICAL SOLUTIONS, INC. |
ROLLINS 7 OXYGEN MASK |
10/09/2013 |
K992285 |
SALTER LABS |
SALTER AIRE COMPRESSOR |
01/07/2000 |
K962085 |
SALTER LABS |
SALTER LABS 8990 SERIES NEBULIZER |
08/26/1996 |
K014056 |
SALTER LABS |
SALTER LABS MODIFIED NEBUTECH NEBULIZER |
02/01/2002 |
K983403 |
SALTER LABS |
SALTER LABS NEBULIZER EXHALATION AEROSOL FILTER |
12/17/1998 |
K991788 |
SALTER LABS |
SALTER LABS PEP DEVICE |
08/06/1999 |
K992986 |
SALTER LABS |
SALTER LABS SINGLE PATIENT USE EXHALATION AEROSOL FILTER |
09/24/1999 |
K962879 |
SALTER LABS |
SALTERLABS 8660 SERIES NEBULIZER |
10/22/1996 |
K961476 |
SALTER LABS |
SALTERLABS 8960 SERIES NEBULIZER (8960/8961/8966/8984) |
07/16/1996 |
K002543 |
SAN UP S.A. |
COMOACT ULTRASONIC NEBULIZER, MODEL 3060 |
06/14/2001 |
K032516 |
SENSORMEDICS CORP. |
HIOX80 AEROSOL ADAPTER |
03/04/2004 |
K170886 |
Shenzhen Homed Medical Device Co,.Ltd. |
HOMED Mesh Nebulizer |
06/21/2018 |
K161586 |
SHENZHEN HOMED MEDICAL DEVICE CO., LTD |
The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS) |
09/06/2017 |
K212395 |
Shenzhen Homed Medical Device Co., Ltd. |
Nebulizer |
03/25/2022 |
K201397 |
Shenzhen Ivankaca Technology Co., Ltd |
Ultrasonic Mesh Nebulizer |
06/14/2021 |
K031370 |
SHINING WORLD HEALTH CARE CO., LTD. |
SHINMED MODE SW-988 UNTRASONIC NEBULIZER |
09/01/2004 |
K980024 |
SHINING WORLD HEALTH CARE CO., LTD. |
SHINMED MODEL SW-966 ULTRASONIC NEBULIZER |
09/03/1999 |
K050183 |
SILVESTRIN FABRIS S.R.L. |
SILFAB SUPER 2 MAX COMPRESSOR, N28 SERIES |
08/16/2005 |
K101953 |
SOUTHMEDIC, INC. |
SMDIA-1000 |
01/07/2011 |
K980829 |
STERIPAK, LTD. |
3ML STERI-NEB SALINE - 0.9% W/V SODIUM CHLORIDE INHALATION SOLUTION USP |
06/02/1998 |
K091794 |
STEVE ISLAVA |
CARE2 MEDICAL NEBULIZER, MODEL 101/102, 201/202 |
01/28/2010 |
K020932 |
SUNRISE MEDICAL |
DEVILBISS PULMO-AIDE COMPACT COMPRESSOR |
06/28/2002 |
K993492 |
SUNRISE MEDICAL HHG, INC. |
DEVILBISS NEBULIZER MODEL 800 |
04/21/2000 |
K140237 |
SUZHOU WEIKANG MEDICAL APPARATUS CO., LTD |
DISPOSABLE NEBULIZER SET |
01/08/2015 |
K971981 |
SYSTAM |
LS SERIES 200 FLOVISION SYSTEM |
12/22/1998 |
K122060 |
TaiDoc Technology Corporation |
CLEVER TD-7001NEBULIZER |
03/21/2013 |
K121969 |
TaiDoc Technology Corporation |
U-RIGHT COMPRESSOR NEBULIZER |
02/28/2013 |
K141214 |
Teleflex Medical, Inc. |
AQUAPAK NEBULIZER ADAPTORS/RESERVOIRS |
12/18/2014 |
K142153 |
Teleflex Medical, Inc. |
HUDSON RCI ADDIPAK UNIT DOSE VIAL, 0.9% FULL NORMAL SALINE SOLUTION, 3ML;5ML;15ML |
04/29/2015 |
K153010 |
Teleflex Medical, Inc. |
Hudson RCI AquaPak Sterile Prefilled Nebulizers |
07/26/2016 |
K080230 |
Teleflex Medical, Inc. |
NEB-U-MASK SYSTEM, MODELS 1895, 1896 |
06/09/2008 |
K972657 |
TEXAS MEDICAL INDUSTRIES, INC. |
ULTRAMIST 2000 |
02/02/1998 |
K955805 |
THAYER MEDICAL CORP. |
DUAL SPRAY MINISPACER |
03/21/1996 |
K972237 |
THAYER MEDICAL CORP. |
HAND HELD MEDISPACER |
07/31/1997 |
K993101 |
THAYER MEDICAL CORP. |
LITEAIRE |
10/26/2000 |
K102658 |
THAYER MEDICAL CORP. |
MINISPACER DUAL-SPRAY MDI ADAPTER WITH 22MM (OR 15MM) OD / 22MM OD/ID CONNECTIONS / 15MM ID CONNECTIONS |
12/10/2010 |
K992722 |
THAYER MEDICAL CORP. |
PRIMEAIRE |
11/10/1999 |
K111570 |
THAYER MEDICAL CORPORATION |
MINISPACER(R) MDI ADAPTER WITH COUNTER INCREMENTING ACTUATOR |
09/29/2011 |
K210126 |
The Ritedose Corporation |
Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10% |
12/03/2021 |
K982179 |
TRUDELL MEDICAL |
TRUMIST AIR ENTRAINED DISPOSABLE NEBULIZER |
09/17/1998 |
K982181 |
TRUDELL MEDICAL |
TRUMIST BREATH ACTUATED DISPOSABLE NEBULIZER |
01/08/1999 |
K992917 |
TRUDELL MEDICAL INT'L |
AEROCHAMBER PLUS VALVED HOLDING CHAMBER |
09/14/1999 |
K001137 |
TRUDELL MEDICAL INT'L |
AEROTRACH PLUS VALVED HOLDING CHAMBER (VHC) |
07/05/2000 |
K140919 |
TRUDELL MEDICAL INT'L |
RESPICONNECT ADAPTER |
08/15/2014 |
K200063 |
Trudell Medical International |
AeroEclipse* ONE BAN |
07/17/2020 |
K203400 |
Trudell Medical International |
Corrugated tube with mouthpiece accessory |
06/14/2021 |
K173367 |
Trudell Medical International |
MC 300* Nebulizer |
02/28/2018 |
K173825 |
Trudell Medical International |
MC 300R* Nebulizer |
05/02/2018 |
K032972 |
TRUDELL MEDICAL INTL. |
AEROCHAMBER MAX VALVED HOLDING CHAMBER |
01/14/2004 |
K090065 |
TRUDELL MEDICAL INTL. |
AEROCHAMBER MINI VENTILATION CHAMBER |
04/09/2009 |
K080926 |
TRUDELL MEDICAL INTL. |
AEROECLIPSE DURABLE BREATH ACTUATED NEBULIZER |
08/12/2008 |
K053605 |
TRUDELL MEDICAL INTL. |
AEROECLIPSE II BREATH ACTUATED NEBULIZER |
02/27/2006 |
K123614 |
TRUDELL MEDICAL INTL. |
SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS) |
03/11/2013 |
K962872 |
TYCO HEALTHCARE DEUTSCHALAND GMBH |
RESPIFLO |
02/25/1997 |
K220869 |
Vapotherm Inc. |
Vapotherm Aerosol Adapter AAA-2 |
10/28/2022 |
K142059 |
VECTURA GMBH |
FOX MOBILE |
01/09/2015 |
K002831 |
VEGA TECHNOLOGIES, INC. |
VEGA ULTRASONIC NEBULIZER |
05/23/2001 |
K981944 |
VENTLAB CORP. |
BREATHERITE |
08/24/1998 |
K090840 |
VENTLAB CORP. |
VENTLAB 5000 SERIES NEBULIZER ASSEMBLY, CUP, CUP W/ MASK, CUP W/ FITSALL CONN. |
06/25/2009 |
K962438 |
VITAL SIGNS, INC. |
MISTY OX TURBOHEATER |
01/13/1997 |
K963910 |
VORTRAN MEDICAL TECHNOLOGY 1, INC. |
HEART NEBULIZER #100609 |
12/16/1996 |
K072136 |
WILFRED KROMKER GMBH |
ULTRASONIC NEBULISER MODEL 2010 |
07/15/2008 |