FDA 510(k) Applications for Medical Device Product Code "BZD"
(Ventilator, Non-Continuous (Respirator))

FDA 510(k) Number Applicant Device Name Decision Date
K133769 3B MEDICAL, INC 3B RESMART BPAP 25A, BMC RESMART BPAP 25A 08/25/2014
K131707 3B MEDICAL, INC 3B RESMART CPAP AND AUTO CPAP SYSTEMS, BMC RESMART CPAP AND AUTO CPAP SYSTEMS 08/22/2013
K132967 3B MEDICAL, INC 3B RESMART CPAP AND AUTO CPAP, BMC RESMART CPAP AND AUTO CPAP 12/06/2013
K131901 3B MEDICAL, INC IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2 12/23/2013
K141770 3B MEDICAL, INC LUNA CPAP AND AUTO-CPAP SYSTEM 04/22/2015
K160127 3B MEDICAL, INC. iCodeConnect 11/10/2016
K153387 3B MEDICAL, INC. Luna CPAP and Auto CPAP System 09/08/2016
K110629 3B PRODUCTS, INC. RESMART CPAP, RESMART AUTO-CPAP AND RESMART HUMIDIFIER 04/27/2012
K103434 3B PRODUCTS, LLC 3B FLEX-LITE 10/13/2011
K112271 3B PRODUCTS, LLC 3B WILLOW 02/16/2012
K110471 A PLUS MEDICAL BABI PLUS INFANT NASAL CANNULA SYSTEM 10/07/2011
K093716 A PLUS MEDICAL BABI PLUS INFANT NASAL CANNULA SYSTEM 05/13/2010
K110383 A PLUS MEDICAL BABI*PLUS PRESSURE RELIEF MANIFOLD - 10CM H20, 12.5CM H20, 15CM H20 08/01/2011
K823936 ACKRAD LABORATORIES CPAP INFANT NASAL CANNULAE SET 01/28/1983
K841773 ACKRAD LABORATORIES INFANT NASAL CANNULAE ASSEMBLY 07/26/1984
K911780 ACKRAD LABORATORIES INFANT NASAL CANNULAE ASSEMBLY, MODIFIED 06/24/1991
K895031 ACKRAD LABORATORIES MODIFIED INFANT NASAL CANNULAE ASSEMBLY 10/30/1989
K042130 AEIOMED INC. AURA CPAP PATIENT INTERFACE 09/08/2004
K042945 AEIOMED INC. AURA CPAP SYSTEM 03/09/2005
K100121 AEIOMED, INC. MODEL 300157 CPAP SYSTEM 07/13/2010
K072993 AEIOMED, INC. REUSABLE HEADREST WITH NASAL SEAL 02/08/2008
K943207 AIRSEP CORP. NITELIFE BI-LEVEL CPAP 07/29/1996
K122350 AIRWAY MANAGEMENT, INC. TAP PAP NASAL PILLOW MASK 11/01/2012
K951944 AIRWAYS LTD., INC. NASALFLAIR 03/28/1997
K150111 APEX MEDICAL CORP. Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series 09/15/2015
K141522 APEX MEDICAL CORP. APEX MEDICAL CORP. ICH CPAP WITH PVA 9S-007XXX SERIES 10/06/2014
K041828 APEX MEDICAL CORP. APEX MEDICAL CPAP MODEL 9S-003 07/30/2004
K022650 APEX MEDICAL CORP. APEX MEDICAL CPAP RT 21XX 02/04/2004
K120035 APEX MEDICAL CORP. APEX MEDICAL ICH CPAP SERIES (9S-007XXX) 05/16/2012
K103174 APEX MEDICAL CORP. APEX MEDICAL WIZARD SERIES CPAP MASK 05/06/2011
K083656 APEX MEDICAL CORP. APEX MEDICAL XT AUTO CPAP 9S-005200 04/22/2009
K112079 APEX MEDICAL CORP. APEX MEDICAL XT AUTO CPAP WITH COMPLIANCE IMPROVEMENT ALGORITHM 9S-005720 12/06/2012
K070609 APEX MEDICAL CORP. APEX MEDICAL XT1 CPAP, MODEL 9S-005 05/04/2007
K121642 APEX MEDICAL CORP. WIZARD 230 NASAL PILOW MASK 06/06/2013
K071915 ARCIMED LABORATORIES LLC CPAP MASK 05/14/2008
K864883 BEHAN & TAYLOR ENT. NEONATAL CANNULA CAP 01/28/1987
K863746 BIRD PRODUCTS CORP. BIRD NIGHTBIRD NASAL CPAP SYSTEM 12/15/1986
K990856 BIRD PRODUCTS CORP. HERITAGE NASAL CPAP SYSTEM, MODEL P/N 15682 01/11/2000
K020730 BIRD PRODUCTS CORP. ORION NASAL CPAP SYSTEM 05/22/2002
K133009 BMC MEDICAL CO., LTD NASAL MASK, NASAL MASK, FULL FACE MASK 04/23/2014
K163464 BMC MEDICAL.,LTD. Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2) 09/05/2017
K061057 BREAS MEDICAL AB BREAS ISLEEP 20+ 06/23/2006
K063476 BREAS MEDICAL AB BREAS ISLEEP 20I 01/22/2007
K060657 BREAS MEDICAL AB ISLEEP BY BREAS, MODELS ISLEEP 10, ISLEEP 20. 08/18/2006
K130037 BREATHE TECHNOLOGIES, INC. BREATHE CPAP SYSTEM 05/17/2013
K990659 BREATHING TECHNOLOGIES CORP. NASAL AIRE 11/26/1999
K040862 CARADYNE, LTD. GUARDIAN NEONATE CPAP/HUMIDIFICATION SYSTEM 06/30/2004
K050994 Cardinal Health AIRLIFE INFANT NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM 08/03/2005
K051226 Cardinal Health AIRLIFE NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE (NCPAP) SYTEM DRIVER 11/17/2005
K093124 CARDINAL HEALTH 207, INC. PURESOM NASAL MASK-SMALL, PURESOM NASAL MASK-MEDIUM, PURESOM NASAL MASK-LARGE, MODELS 11924-01, 11924-02, 11924-03 03/10/2010
K103410 CHILDRENS MEDICAL VENTURES LLC NEOPAP SYSTEM 03/30/2011
K130481 CIRCADIANCE LLC SLEEPWEAVER ANEW FULL FACE SOFT CLOTH PAP MASK 05/24/2013
K120757 CIRCADIANCE LLC SLEEPWEAVER ELAN NASAL CPAP MASK 04/24/2012
K092362 CIRCADIANCE LLC SLEEPWEAVER NASAL CPAP MASK 11/02/2009
K162905 Circadiance, LLC SleepWeaver 3D Nasal Mask 03/15/2017
K151683 Circadiance, LLC SleepWeaver Advance Pediatric Nasal CPAP Mask 04/05/2016
K130663 CURATIVE MEDICAL INC. BESTFIT2 NASAL MASK 09/27/2013
K120285 CURATIVE MEDICAL INC. K SERIES CPAP SYSTEM WITH HEATED HUMIDIFER 07/02/2012
K123897 CURATIVE MEDICAL INC. K SERIES CPAP SYSTEMS 03/13/2013
K130828 CURATIVE MEDICAL INC. K SERIES CPAP SYSTEMS 01/13/2014
K131702 CURATIVE MEDICAL INC. K SERIES CPAP SYSTEMS 12/06/2013
K121374 DESHUM MEDICAL ZI BLOWER 02/22/2013
K935979 DEVILBISS HEALTH CARE, INC. CONTINUOUS POSITIVE AIRWAY PRESSURE CPAP SYSTEM 11/10/1994
K904766 DEVILBISS HEALTH CARE, INC. DEVILBISS MODEL 7352 SERIES 03/26/1991
K950849 DEVILBISS HEALTH CARE, INC. MODEL #7354 02/08/1996
K952491 DEVILBISS HEALTH CARE, INC. MODEL 7355 01/31/1996
K904344 DEVILBISS HEALTH CARE, INC. SLEEPER MASK SYSTEM 05/01/1991
K112220 DEVILBISS HEALTHCARE LLC DEVILBISS INTELLIPAP / SLEEPCUBE AUTO BILEVEL 11/22/2011
K140880 DEVILBISS HEALTHCARE LLC DEVILBISS SMARTLINK II SYSTEM 08/04/2014
K152810 DeVilbiss Healthcare, LLC DeVilbiss DV6WM Wireless Modem 01/21/2016
K143677 DeVilbiss Healthcare, LLC DeVilbiss Intellipap2/DeVilbiss BLUE 09/18/2015
K011516 EME (ELECTRO MEDICAL EQUIPMENT) LTD. INFANT FLOW SYSTEM, MODEL M672P 06/08/2001
K972605 ENGINEERED MEDICAL SYSTEMS EMS NASAL CPAP MASK 01/28/1998
K023683 ENGINEERED MEDICAL SYSTEMS MULTI-STRAP FULL FACE MASK 12/01/2003
K000215 ENGINEERED MEDICAL SYSTEMS SWIVEL ELBOW 05/26/2000
K973161 FISHER & PAYKEL ELECTRONICS LTD. CPAP HUMIDIFIER (HC 200) 07/10/1998
K121597 FISHER & PAYKEL HEALTHCARE LIMITED ESON NASAL MASK 10/02/2012
K153505 FISHER & PAYKEL HEALTHCARE LIMITED F&P Eson 2 Nasal Mask 09/20/2016
K130328 FISHER & PAYKEL HEALTHCARE LIMITED F&P SIMPLUS FULL FACE MASK 06/05/2013
K120027 FISHER & PAYKEL HEALTHCARE LIMITED PILAIRO NASAL PILLOWS MASK 02/23/2012
K173193 Fisher & Paykel Healthcare Ltd F&P SleepStyle 08/08/2018
K161412 Fisher & Paykel Healthcare Ltd. F&P BrevidaÖ Nasal Pillows Mask 01/18/2017
K161686 FISHER & PAYKEL HEALTHCARE LTD. F&P InfoSmart 01/24/2017
K040941 FISHER & PAYKEL HEALTHCARE, LTD. CPAP HUMIDIFIER, MODEL HC234 (AND RELATED ACCESSORIES) 06/10/2004
K050904 FISHER & PAYKEL HEALTHCARE, LTD. CPAP HUMIDIFIER, MODEL HC238JHU 05/25/2005
K094040 FISHER & PAYKEL HEALTHCARE, LTD. F&P ICON SERIES CPAP 04/27/2010
K100011 FISHER & PAYKEL HEALTHCARE, LTD. FISHER & PAYKEL HEALTHCARE BUBBLE CPAP SYSTEM 10/08/2010
K023559 FISHER & PAYKEL HEALTHCARE, LTD. FISHER & PAYKEL HEALTHECARE ORACLE ORAL MASK 06/12/2003
K080209 FISHER & PAYKEL HEALTHCARE, LTD. FISHER AND PAYKEL HEALTHCARE ZEST NASAL MASK 09/12/2008
K040506 FISHER & PAYKEL HEALTHCARE, LTD. FLEXIFIL SERIES HC431 FULL FACE MASK, MODEL HC431A 05/05/2004
K061236 FISHER & PAYKEL HEALTHCARE, LTD. FLEXIFIT HC432 FULL FACE MASK 08/29/2006
K041900 FISHER & PAYKEL HEALTHCARE, LTD. HC604 CPAP HUMIDIFIER 08/31/2004
K110316 FISHER & PAYKEL HEALTHCARE, LTD. INFOSEND GSM 08/19/2011
K063036 FISHER & PAYKEL HEALTHCARE, LTD. OPUS HC482 DIRECT NASAL MASK 12/22/2006
K003894 FISHER & PAYKEL HEALTHCARE, LTD. ORACLE ORAL MASK 06/25/2001
K033087 FISHER & PAYKEL HEALTHCARE, LTD. ORACLE ORAL MASK, MODEL HC451A 01/14/2004
K023670 FISHER & PAYKEL HEALTHCARE, LTD. SINGLE USE ORAL MASK, MODEL HC455A 06/12/2003
K081029 FISHER & PAYKEL HEALTHCARE, LTD. SLEEPSTYLE 200 AUTO SERIES HC254 09/12/2008
K083832 FISHER & PAYKEL HEALTHCARE, LTD. ZEST NASAL MASK 03/16/2009
K103786 FISHER & PAYKEL HEALTHCARE, LTD. ZEST PETITE NASAL MASK 03/24/2011
K072755 GALEMED CORP. GALEMED CPAP MASK 11/16/2007
K022934 GOTTLIEB WEINMANN GERAETE FUER MEDIZIN UND ARBEITS SILENTFLOW 2 EXHALATION SYSTEM, MODEL WM 23650 11/14/2002
K013738 GOTTLIEB WEINMANN GERAETE FUER MEDIZIN UND ARBEITS WEINMANN SOMNOMASK 01/22/2002
K030563 HAMILTON MEDICAL AG ARABELLA NCPAP MASKS 09/09/2003
K030822 HANS RUDOLPH, INC. 7600 SERIES MULTI-PATIENT MULTI-USE ORO-NASAL CPAP/NPPV MASKS 06/03/2003
K020759 HANS RUDOLPH, INC. 7600 SERIES REUSABLE FULL-FACE CPAP/NIPPV MASKS MODELS 7620 LARGE, 7630 MEDIUM, 7640 SMALL, 7650 EXTRA SMALL, 7660 PETIT 08/13/2002
K071149 HANS RUDOLPH, INC. HRI 6500, 6600 AND 6700 SERIES V2MASKS 02/01/2008
K943509 HEALTHDYNE TECHNOLOGIES, INC. 7300 NASAL CPAP SYSTEM 08/05/1994
K970173 HEALTHDYNE TECHNOLOGIES, INC. MODEL 1700 TRANQUILITY BILEVEL SYSTEM 04/16/1997
K974879 HEALTHDYNE TECHNOLOGIES, INC. MODEL 7410 VOYAGER 06/29/1998
K974453 HEALTHDYNE TECHNOLOGIES, INC. NASAL INTERFACE MODEL 7910 08/04/1998
K950331 HEALTHDYNE, INC. PRESSURE SUPPORT VENTILATORY ASSIST SYSTEM (PSVAS) 09/21/1995
K052597 HOFFMAN LABORATORIES, LLC BREATHEX OMEGA CPAP DEVICE, MODEL 322 12/16/2005
K061099 HOFFMAN LABORATORIES, LLC BREATHX NASAL PILLOW AND MASK SYSTEM, MODEL 011-0003 08/11/2006
K041035 HOFFRICHTER GMBH HOFFRICHTER TREND 110 CPAP DEVICE WITH AQUATREND III CPAP HUMIDIFIER ACCESSORY FOR TREND 06/09/2004
K014074 HOFFRICHTER GMBH HOFFRICHTER VECTOR, VECTOR PLUS, VECTOR BI-VEVEL, VECTOR BI-LEVEL PLUS, SCALAR, SCALAR PLUS; CPAP WITH HUMIDIFIER OPTION 07/23/2003
K053486 HOFFRICHTER GMBH TREND 200 CPAP DEVICE, MODEL 5CP201; TRENDSET PC SOFTWARE, MODEL TRENDSET 01/04/2006
K871351 HOLTER-HAUSNER INTL. H-H HARRIS NEONATAL NASAL CANNULA SET FOR CPAP 05/14/1987
K063268 HSINER CO., LTD. CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235 02/23/2007
K120920 HSINER COMPANY HSINER CPAP SILICONE NASAL MASK SIZE XS/PETITE HSINER NASAL PILLOW MASK HSINER INFANT CPAP CANNULA 07/16/2012
K871157 HUDSON OXYGEN THERAPY SALES CO. C.P.A.P. NASAL CANNULA 04/21/1987
K140929 HUMAN DESIGN MEDICAL, LLC Z1 CPAP SYSTEM 10/17/2014
K853487 INFRASONICS CORP. PATIENT BREATHING CIRCUIT 09/06/1985
K050171 INNOMED TECHNOLOGIES IT NASAL MASK 05/04/2005
K022465 INNOMED TECHNOLOGIES MODIFICATION TO NASAL-AIRE 03/21/2003
K090804 INNOMED TECHNOLOGIES INC./RESPCARE INC. NASAL AIRE II PEDIATRIC, MODEL 5 SIZES, MODEL TBD 11/05/2009
K933184 INNOVATIVE MEDICAL SYSTEMS, INC. POSITIVE AIRWAY PRESSURE SYSTEM 11/28/1994
K150365 inSleep Technologies, LLC Cloud9 System 07/21/2015
K121747 INTERSURGICAL INCORPORATED FACEFIT AND FACEFIT PORTED NON-INVASIVE VENTILATION MASKS 03/14/2013
K982242 INVACARE CORP. INVACARE CPAP 01/27/1999
K031064 INVACARE CORP. INVACARE POLARIS EX CPAP, MODEL ISP3000 03/12/2004
K061874 INVACARE CORP. INVACARE'S TWILIGHT II NASAL MASKS 09/05/2006
K070321 INVACARE CORP. TWILIGHT FULL FACE MASK 04/30/2007
K022642 INVACARE CORP. TWLIGHT, MODEL ISP 9600 02/11/2003
K130686 LAKEVIEW SLEEP CENTER NASAL COMFORT FREEDOM 10/16/2013
K862448 LIFE DESIGN SYSTEMS, INC. FLOW GENERATOR FOR SLEEP APNEA, LDS 1500 11/14/1986
K933947 LIFECARE INTERNATIONAL,INC. LIFECARE CPAP-200 11/10/1994
K912224 LIFECARE SERVICES, INC. LIFECARE CPAP-100 09/23/1991
K013421 LIFEGUARD MEDICAL PRODUCTS, INC. LIFEGUARD NASAL CPAP MASK AND ACCESSORIES 01/08/2002
K071773 LIFESOURCE CPAP NASAL MASK WITH PILLOWS 09/12/2007
K041819 MALLINCKRODT DEVELOPPEMENT FRANCE GOODKNIGHT 425, MODELM-114500-00 07/22/2004
K063501 MALLINCKRODT DEVELOPPEMENT FRANCE KNIGHTCONTROL REMOTE CONTROL, MODEL M-114700-US 04/06/2007
K001845 MALLINCKRODT DEVELOPPEMENT FRANCE MALLINCKRODT, GOODKNIGHT 418S 07/05/2000
K082237 MALLINCKRODT DEVELOPPEMENT FRANCE PURITAN BENNETT, SANDMAN DUO AND SANDMAN DUO ST 10/09/2008
K080439 MALLINCKRODT DEVELOPPEMENT FRANCE SANDMAN INFO WITHOUT HUMIDIFIER/ SANDMAN AUTO WITHOUT HUMIDIFIER, MODEL M-114801-114802-US; SANDMAN INFO WITH INTERGRATE 05/16/2008
K071575 MALLINCKRODT DEVELOPPEMENT FRANCE SANDMAN INTRO 09/10/2007
K993094 MAP MEDIZINTECHNIK FUR ARZT UND PATIENT GMBH AERO-CLICK 10/23/2000
K023068 MAP MEDIZINTECHNIK FUR ARZT UND PATIENT GMBH PAPILLON MASK SET 05/28/2003
K060067 MASKMEDIC MASKMEDIC CONCEPT NASAL MASK 07/14/2006
K002763 MEDICAL INDUSTRIES AMERICA, INC. REMREST 05/04/2001
K905593 MEDICAL INDUSTRIES AMERICA, INC. SLEEPAP 04/23/1991
K861280 MEDICOMP, INC. MEDICOMP CPAP NASAL CANNULA 05/09/1986
K905404 MEDTRONIC VASCULAR MEDTRONIC SULLIVAN NASAL CPAP SYSTEM 05/13/1991
K041823 MERITS HEALTH PRODUCTS CO., LTD. PIONEER U121 SERIES CPAP 05/10/2005
K993584 NELLCOR PURITAN BENNETT FRANCE DVPT. MALLINCKRODT, GOODKNIGHT 418A, GOODKNIGHT 418P, SILVERLINING 2 03/07/2000
K991150 NELLCOR PURITAN BENNETT FRANCE DVPT. NELLCOR PURITAN BENNETT, GOODKNIGHT 418G 04/14/1999
K980365 NELLCOR PURITAN BENNETT, INC. GOODKNIGHT 418 CPAP SYSTEM 07/22/1998
K050072 NELLCOR PURITAN BENNETT, INC. GOODKNIGHT 425ST 06/13/2005
K964019 NELLCOR PURITAN BENNETT, INC. MORPHEE PLUS ALPHA 06/18/1997
K952966 NIDEK MEDICAL PRODUCTS, INC. CP-90 CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM 05/07/1996
K980551 NIDEK MEDICAL PRODUCTS, INC. SILENZIO DELTA CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM 11/17/1998
K792722 NOVAMETRIX MEDICAL SYSTEMS, INC. NOVAMETRIX CPAP NASAL CANNULA 01/24/1980
K991926 OPAP, INC. OPAP 10/18/1999
K931484 PORTABLE POWER SYSTEMS, INC. REPLACEMENT BATTER FOR ABBOTT LABS LIFECARE 4100 S 02/17/1994
K010704 PRYM MEDICAL LTD. DORNIR LC-1 CPAP SYSTEM 04/18/2001
K000888 PRYM MEDICAL LTD. SANSIBAR CPAP SYSTEM 08/15/2000
K100343 PUR-SLEEP, INC. PAP-CAP 04/23/2010
K923590 PURITAN BENNETT CORP. 318A RESPIRATORY SUPPORT SYSTEM 04/09/1993
K002001 PURITAN BENNETT CORP. BREEZE SLEEPGEAR WITH DREAMSEAL 09/06/2000
K910194 PURITAN BENNETT CORP. COMPANION 318 NASAL CPAP DIAGNOSTICS SYSTEM 05/13/1991
K852821 PURITAN BENNETT CORP. DISPOSABLE VVC(VOLUME VENTILATOR CIRCUIT) 07/29/1985
K934804 PURITAN BENNETT CORP. PURITAN-BENNETT COMPANION 320 I/E 02/27/1995
K952292 PURITAN BENNETT CORP. PURITAN-BENNETT COMPANION NASAL CPAP SYSTEM 11/13/1995
K960518 PURITAN BENNETT CORP. THE PURITAN-BENNETT 318 PLUS NASAL CPAP SYSTEM 05/09/1996
K935784 PURITAN-BENNETT PURITAN-BENNETT COMPANION 320 I/E BI-LEVEL RESPIRATORY SYSTEM 07/13/1994
K080516 REMGENIC LLC LAMIN AIR 06/23/2008
K952429 RESCARE LTD. RES CARE AUTO SET CLINICAL, PORTABLE SYSTEM, PORTABLE 2 SYSTEM 07/02/1996
K930656 RESCARE LTD. SULLIVAN III NASAL CPAP SYSTEM 03/15/1994
K931884 RESCARE LTD. SULLIVAN NASAL VPAP SYSTEM 06/07/1994
K952475 RESCARE LTD. SULLIVAN NOSE & MOUTH MASK SYSTEM 05/28/1996
K140124 RESMED CORP S9 ELOUERA 05/12/2014
K113801 RESMED CORP VPAP ADAPT 05/25/2012
K013843 RESMED CORP. AUTOSET SPIRIT CPAP SYSTEM 07/16/2002
K090490 RESMED CORP. MIRAGE ECHO 05/06/2009
K013909 RESMED CORP. S7 ELITE CP AP SYSTEM 07/08/2002
K030797 RESMED CORP. S7 ELITE CPAP SYSTEM WITH SOMNOTRAXX SYSTEM; AUTOSET SPIRIT CPAP SYSTEM WITH SOMNOTRAXX SYSTEM 03/10/2004
K111148 RESMED CORP. S8 ASPEN WITH H4I PLUS 06/30/2011
K170924 ResMed Ltd AirFit F20 01/03/2018
K153673 ResMed Ltd AirFit N20 05/02/2016
K161978 ResMed Ltd AirFit N20 11/17/2016
K171212 ResMed Ltd AirFit N20 09/28/2017
K160836 ResMed Ltd Menai System 12/15/2016
K140054 RESMED LTD RESCAN 05/16/2014
K160822 RESMED LTD S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV 09/09/2016
K180497 ResMed Ltd Scone Mask 06/15/2018
K153563 RESMED LTD. AirFit F20 05/13/2016
K132887 RESMED LTD. AIRFIT N10 12/20/2013
K132901 RESMED LTD. AIRSOFT F15 06/09/2014
K032480 RESMED LTD. AUTOSET SPIRIT SYSTEM 10/16/2003
K143603 RESMED LTD. Darlinghurst Vented, Darlinghurst NV-AAV 05/21/2015
K093684 RESMED LTD. EASYCARE ONLINE 02/26/2010
K113780 RESMED LTD. EASYCARE TX SYSTEM (CONNEXUNS) 04/20/2012
K092026 RESMED LTD. EASYCARE TX, TX LINK 10/02/2009
K121705 RESMED LTD. GEO 10/23/2012
K032916 RESMED LTD. MIRAGE ACTIVA MASK 12/04/2003
K030798 RESMED LTD. MIRAGE ACTIVA MASK 04/09/2003
K023244 RESMED LTD. MIRAGE FULL FACE MASK SERIES 2 11/27/2002
K023284 RESMED LTD. MIRAGE FULL FACE MASK SERIES 2 11/27/2002
K023306 RESMED LTD. MIRAGE FULL FACE MASK SERIES 2 11/27/2002
K102746 RESMED LTD. MIRAGE FX 12/28/2010
K063011 RESMED LTD. MIRAGE LIBERTY FULL FACE MASK 02/02/2007
K072940 RESMED LTD. MIRAGE MICRO 12/13/2007
K071808 RESMED LTD. MIRAGE MICRO 10/10/2007
K110444 RESMED LTD. MIRAGE MICRO 03/16/2011
K100772 RESMED LTD. MIRAGE MICRO MODEL 16333 (S), 16334 (M&L), 16335 (LW & XL) 06/09/2010
K113127 RESMED LTD. MIRAGE QUATTRO 01/06/2012
K063122 RESMED LTD. MIRAGE QUATTRO FULL FACE MASK 02/02/2007
K042403 RESMED LTD. MIRAGE SWIFT 10/08/2004
K031047 RESMED LTD. MIRAGE VISTA MASK 08/19/2003
K081321 RESMED LTD. MODIFICATION TO MIRAGE MICRO 10/09/2008
K032433 RESMED LTD. NASAL JACKS MASK 10/24/2003
K033914 RESMED LTD. OXYGEN DIVERTER VALVE 04/22/2004
K102224 RESMED LTD. PIXI PEDIATRIC MASK 12/10/2010
K061200 RESMED LTD. PRESTIGE CPAP FLOW GENERATOR WITH PRESTIGE HUMIDIFIER 07/20/2006
K123979 RESMED LTD. QUATTRO AIR 02/27/2013
K091129 RESMED LTD. QUATTRO LT 08/03/2009
K051314 RESMED LTD. RES TRAXX DATA CENTER 07/15/2005
K053205 RESMED LTD. RES TRAXX DATA CENTER 02/03/2006
K083816 RESMED LTD. RES TRAXX ONLINE, MODEL: R14 03/20/2009
K034033 RESMED LTD. RESCAN 05/05/2004
K040944 RESMED LTD. RESCONTROL II 06/03/2004
K041362 RESMED LTD. RESMED HOSPITAL FULL FACE MASK 07/15/2004
K040566 RESMED LTD. RESMED HOSPITAL NASAL MASK 04/02/2004
K050142 RESMED LTD. RESMED MERIDIAN MASK 03/01/2005
K041209 RESMED LTD. RESMED S8 PIONEER CPAP SYSTEM 07/01/2004
K033841 RESMED LTD. RESMED S8 PRIME CPAP SYSTEM 03/10/2004
K050775 RESMED LTD. RESSCAN 05/10/2005
K082983 RESMED LTD. RESSCAN-PRO 01/02/2009
K070746 RESMED LTD. RESTRAXX DATA CENTRE, MODEL R10 07/13/2007
K024191 RESMED LTD. S7 ELITE AND AUTOSET SPIRIT CPAP SYSTEMS WITH RESLINK 07/02/2003
K082979 RESMED LTD. S8 ADVANCE 01/02/2009
K091947 RESMED LTD. S8 ASPEN WITH H4I PLUS 09/28/2009
K080079 RESMED LTD. S8 ESCAPE II 04/08/2008
K132606 RESMED LTD. S9 CRONULLA FOR HER 01/13/2014
K140279 RESMED LTD. S9 GREENHILLS 07/31/2014
K102586 RESMED LTD. S9 VPAP ADAPT WITH H5I 03/18/2011
K102513 RESMED LTD. S9 VPAP ST WITH H5I 01/05/2011
K140159 RESMED LTD. S9 WANDA VPAP ST 06/17/2014
K980721 RESMED LTD. SULLIVAN AUTOSET 09/01/1998
K970516 RESMED LTD. SULLIVAN AUTOSET HOME NASAL CPAP SYSTEM 05/09/1997
K984428 RESMED LTD. SULLIVAN AUTOSET NASAL CPAP SYSTEM 07/26/1999
K970771 RESMED LTD. SULLIVAN AUTOSET PORTABLE II NASAL CPAP SYSTEM 06/20/1997
K982530 RESMED LTD. SULLIVAN MIRAGE FULL FACE MASK 10/16/1998
K961783 RESMED LTD. SULLIVAN VPAP II ST NASAL VPAP SYSTEM 08/01/1996
K132013 RESMED LTD. SWIFT AIR 10/21/2013
K090244 RESMED LTD. SWIFT FX 04/13/2009
K112489 RESMED LTD. SWIFT FX BELLA 12/07/2011
K123789 RESMED LTD. SWIFT FX NANO 03/29/2013
K073638 RESMED LTD. SWIFT LT 03/20/2008
K112393 RESMED LTD. TASMAN 11/16/2011
K072615 RESMED LTD. TXCONTROL 01/04/2008
K050359 RESMED LTD. ULTRA MIRAGE II MASK 03/16/2005
K071171 RESMED LTD. VPAP AUTO WITH H3I 07/10/2007
K082605 RESMED LTD. VPAP AUTO WITH HUMIDAIRE 3I 01/13/2009
K030843 RESMED LTD. VPAP III 08/15/2003
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