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 |
| K212263 | 3B Medical, Inc. | Luna G3 BPAP System | 03/25/2022 |
| K201620 | 3B Medical, Inc. | Luna« G3 BPAP 25A | 01/29/2021 |
| 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 |
| K093716 | A PLUS MEDICAL | BABI PLUS INFANT NASAL CANNULA SYSTEM | 05/13/2010 |
| K110471 | A PLUS MEDICAL | BABI PLUS INFANT NASAL CANNULA SYSTEM | 10/07/2011 |
| K110383 | A PLUS MEDICAL | BABI*PLUS PRESSURE RELIEF MANIFOLD - 10CM H20, 12.5CM H20, 15CM H20 | 08/01/2011 |
| 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 |
| K182394 | Apex Medical Corp. | WiZARD 310/320 Series CPAP Mask | 05/17/2019 |
| K193206 | Apex Medical Corp. | WiZARD 510 Nasal Mask | 10/29/2020 |
| K071915 | ARCIMED LABORATORIES LLC | CPAP MASK | 05/14/2008 |
| 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 |
| K211155 | BMC Medical Co., Ltd. | Auto CPAP System | 03/09/2022 |
| K242935 | BMC Medical Co., Ltd. | Respiration Data Management Software (PAP Link PC) | 01/15/2025 |
| 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 |
| K950849 | DEVILBISS HEALTH CARE, INC. | MODEL #7354 | 02/08/1996 |
| K952491 | DEVILBISS HEALTH CARE, INC. | MODEL 7355 | 01/31/1996 |
| 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 |
| K243583 | Fisher & Paykel Healthcare Limited | F&P Nova Nasal Mask | 06/18/2025 |
| 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 |
| K221436 | Fisher & Paykel Healthcare Ltd | F&P 950 Accessory Breathing Circuit Kits | 06/29/2023 |
| K212371 | Fisher & Paykel Healthcare Ltd | F&P Evora Full Face Mask | 03/18/2022 |
| K173193 | Fisher & Paykel Healthcare Ltd | F&P SleepStyle | 08/08/2018 |
| K223696 | Fisher & Paykel Healthcare Ltd | F&P Solo Mask Range | 05/17/2023 |
| K161412 | Fisher & Paykel Healthcare Ltd. | F&P BrevidaÖ Nasal Pillows Mask | 01/18/2017 |
| K200089 | Fisher & Paykel Healthcare Ltd. | F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (Small/Med | 06/02/2020 |
| K161686 | FISHER & PAYKEL HEALTHCARE LTD. | F&P InfoSmart | 01/24/2017 |
| K190713 | Fisher & Paykel Healthcare Ltd. | F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Large) | 10/11/2019 |
| 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 |
| K233829 | Fisher and Paykel Healthcare Limited | Nova Micro Pillows Mask Small A Model (NVP1SA); Nova Micro Pillows Mask Medium A Model (NVP1MA); Nova Micro Pillows Mask Large A Model (NVP1LA); Nova Micro Pillows Mask Fit Pack/SML A Model (NVP1SMLA); Nova Micro Pillows Mask Small Sleep Lab A (NVP1SSLA); | 08/23/2024 |
| K072755 | GALEMED CORP. | GALEMED CPAP MASK | 11/16/2007 |
| K243225 | Genadyne Biotechnologies, Inc. | Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L) | 12/31/2024 |
| 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 |
| 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 |
| 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 |
| 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 |
| K140929 | HUMAN DESIGN MEDICAL, LLC | Z1 CPAP SYSTEM | 10/17/2014 |
| K050171 | INNOMED TECHNOLOGIES | IT NASAL MASK | 05/04/2005 |
| K090804 | INNOMED TECHNOLOGIES INC./RESPCARE INC. | NASAL AIRE II PEDIATRIC, MODEL 5 SIZES, MODEL TBD | 11/05/2009 |
| 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 |
| 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 |
| 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 |
| K991926 | OPAP, INC. | OPAP | 10/18/1999 |
| K233555 | Philips Respironics | AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask | 07/31/2024 |
| 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 |
| K002001 | PURITAN BENNETT CORP. | BREEZE SLEEPGEAR WITH DREAMSEAL | 09/06/2000 |
| K960518 | PURITAN BENNETT CORP. | THE PURITAN-BENNETT 318 PLUS NASAL CPAP SYSTEM | 05/09/1996 |
| K080516 | REMGENIC LLC | LAMIN AIR | 06/23/2008 |
| K233415 | RemSleep Holdings | DELTAWAVE Nasal Pillows System | 07/02/2024 |
| K952429 | RESCARE LTD. | RES CARE AUTO SET CLINICAL, PORTABLE SYSTEM, PORTABLE 2 SYSTEM | 07/02/1996 |
| K952475 | RESCARE LTD. | SULLIVAN NOSE & MOUTH MASK SYSTEM | 05/28/1996 |
| K241939 | ResMed Corp | EasyCare Tx 2 | 09/27/2024 |
| K200565 | ResMed Corp | Galapogos | 01/17/2021 |
| K241216 | ResMed Corp | myAir | 09/26/2024 |
| K250624 | ResMed Corp | myAir | 05/28/2025 |
| 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 |
| K183512 | ResMed Ltd | Moore Park Mask | 05/07/2019 |
| 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 |
| K030798 | RESMED LTD. | MIRAGE ACTIVA MASK | 04/09/2003 |
| K032916 | RESMED LTD. | MIRAGE ACTIVA MASK | 12/04/2003 |
| 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 |
| K071808 | RESMED LTD. | MIRAGE MICRO | 10/10/2007 |
| K072940 | RESMED LTD. | MIRAGE MICRO | 12/13/2007 |
| 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 |
| K062291 | RESMED LTD. | VPAP MALIBU WITH H2I | 09/08/2006 |
| K080131 | RESMED LTD. | VPAP ST | 04/01/2008 |
| K242547 | ResMed Pty Ltd | AirFit F20 Mask System; AirFit F20 NM Mask System | 05/19/2025 |
| K203126 | ResMed Pty Ltd | S10 Kirra | 12/18/2020 |
| K234134 | ResMed Pty Ltd (Registration Number: 3004604967) | AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System | 09/24/2024 |
| K230476 | ResMed Pty Ltd (Registration Number: 3004604967) | Oran Park Mask | 10/19/2023 |
| K223747 | ResMed Pty Ltd (Registration Number: 3004604967) | Whitsundays Mask System | 07/06/2023 |
| K052227 | RESPCARE INC. | RESPCARE FACE MASK | 10/28/2005 |
| K062224 | RESPCARE INC. | RESPCARE HYBRID AV MASK | 08/17/2006 |
| K052249 | RESPCARE INC. | UTOPIA | 12/07/2005 |
| K181053 | Respironics Inc. | Care Orchestrator | 01/04/2019 |
| K183226 | Respironics Inc. | Care Orchestrator Essence | 10/18/2019 |
| K122847 | RESPIRONICS INC. | KANGAROO NASAL MASK | 03/06/2013 |
| K152356 | RESPIRONICS INC. | Sapphire | 01/08/2016 |
| K120145 | RESPIRONICS INC. | SIMPLE T NASAL MASK | 03/30/2012 |
| K231313 | Respironics Inc. | Therapy Mask 3100 NC/SP | 07/28/2023 |
| K140580 | RESPIRONICS INC. (DBA PHILIPS RESPIRONICS) | REVOLUTION FULLFACE MASK | 01/16/2015 |
| K091066 | RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP | COMFORT TWIN NASAL MASK | 09/03/2009 |
| K091843 | RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP | COMFORT TWIN NASAL MASK | 09/10/2009 |
| K073600 | RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP | COMFORTGEL FULL FACE MASK | 04/25/2008 |
| K092835 | RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP | COMFORTGEL NASAL MASK | 02/12/2010 |
| K072592 | RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP | PERFORMAX TOTAL FACE MASK | 12/19/2007 |
| K063830 | RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP | REMSTAR AFLEX CPAP SYSTEM | 03/09/2007 |
| K091319 | RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP | REMSTAR AUTO A-FLEX | 08/03/2009 |
| K090243 | RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP | REMSTAR M-SERIES AUTO WITH AFLEX CPAP SYSTEM | 05/08/2009 |
| K091271 | RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP | RESPIRONICS PERFORMAX TOTAL FACE MASK | 05/29/2009 |
| K082866 | RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP | REVOLUTIONFULL FACE MASK | 01/30/2009 |
| K150639 | RESPIRONICS, INC. | AF541 EE Full Face Mask | 09/18/2015 |
| K953341 | RESPIRONICS, INC. | ARIA CPAP SYSTEM | 01/30/1996 |
| K993307 | RESPIRONICS, INC. | ARIA LX CPAP SYSTEM | 10/27/1999 |
| K050759 | RESPIRONICS, INC. | BIPAP AUTO | 06/15/2005 |
| K000994 | RESPIRONICS, INC. | BIPAP DUET LX BI-LEVEL SYSTEM | 06/22/2000 |
| K964363 | RESPIRONICS, INC. | BIPAP DUET SYSTEM | 01/30/1997 |
| K061034 | RESPIRONICS, INC. | BIPAP PLUS M-SERIES BI-LEVEL SYSTEM | 06/23/2006 |
| K032834 | RESPIRONICS, INC. | BIPAP PRO 2 BI-LEVEL SYSTEM | 03/04/2004 |
| K043607 | RESPIRONICS, INC. | BIPAP PRO 2 BI-LEVEL SYSTEM WITH BI-FLEX | 01/28/2005 |
| K011714 | RESPIRONICS, INC. | BIPAP PRO BI-LEVEL SYSTEM | 06/28/2001 |
| K132168 | RESPIRONICS, INC. | BRONCHOSCOPY ELBOW | 11/20/2013 |
| K033759 | RESPIRONICS, INC. | C2 NASAL MASK | 02/19/2004 |
| K053352 | RESPIRONICS, INC. | COMFORTLITE NASAL MASK | 02/15/2006 |
| K082558 | RESPIRONICS, INC. | COMFORTLITE NASAL MASK | 03/25/2009 |
| K200480 | Respironics, Inc. | DreamStation 2 System, DreamStation 2 Advanced System | 07/10/2020 |
| K210844 | Respironics, Inc. | DreamWear Silicone Pillows Mask | 08/24/2021 |
| K954207 | RESPIRONICS, INC. | GEL MASK | 01/31/1996 |
| K102502 | RESPIRONICS, INC. | GOLIFE NASAL MASK | 12/22/2010 |
| K110008 | RESPIRONICS, INC. | GOLIFE NASAL MASK | 02/17/2011 |
| K052110 | RESPIRONICS, INC. | M-SERIES PRO CPAP SYTEM | 10/20/2005 |
| K954572 | RESPIRONICS, INC. | MAESTRO CLINICAL REMOTE CONTROL | 06/26/1996 |
| K210386 | Respironics, Inc. | Magneto Nasal Mask | 07/12/2021 |
| K031460 | RESPIRONICS, INC. | MODIFICATION TO REMSTAR AUTO CPAP SYSTEM | 06/24/2003 |
| K992336 | RESPIRONICS, INC. | MONARCH II MINI MASK | 08/13/1999 |
| K120562 | RESPIRONICS, INC. | PERFORMAX PEDIATRIC EE TOTAL FACE MASK | 07/17/2012 |
| K103395 | RESPIRONICS, INC. | PERFORMAX TOTAL FACE MASK | 03/24/2011 |
| K963250 | RESPIRONICS, INC. | PRESSURE VALVE | 11/14/1996 |
| K963761 | RESPIRONICS, INC. | QUARTET CLINICAL SYSTEM | 04/18/1997 |
| K113068 | RESPIRONICS, INC. | REMSTAR AUTO A-FLEX HT | 12/16/2011 |
| K131982 | RESPIRONICS, INC. | REMSTAR AUTO A-FLEX HT | 10/18/2013 |
| K012554 | RESPIRONICS, INC. | REMSTAR AUTO CPAP SYSTEM | 01/29/2002 |
| K041010 | RESPIRONICS, INC. | REMSTAR AUTO WITH C-FLEX CPAP SYSTEM | 05/05/2004 |
| K010263 | RESPIRONICS, INC. | REMSTAR PLUS CPAP SYSTEM | 03/29/2001 |
| K072996 | RESPIRONICS, INC. | REMSTAR PRO M-SERIES CPAP & HEATED HUMIDIFIER SYSTEM | 12/27/2007 |
| K021861 | RESPIRONICS, INC. | REMSTAR PRO WITH C-FLEX CPAP SYSTEM | 06/19/2002 |
| K122769 | RESPIRONICS, INC. | REMSTAR SE | 10/09/2012 |
| K130077 | RESPIRONICS, INC. | REMSTAR SE | 05/21/2013 |
| K945938 | RESPIRONICS, INC. | RESPIRONICS MONARCH MINI MASK | 01/31/1996 |
| K000705 | RESPIRONICS, INC. | RESPIRONICS SILHOUETTE NASAL MASK, MODELS 1003224 AND 1003223 | 09/08/2000 |
| K091112 | RESPIRONICS, INC. | RESPIRONICS SLEEPEASY CPAP SYSTEM | 05/15/2009 |
| K992969 | RESPIRONICS, INC. | RESPIRONICS TOTAL FACE MASK | 11/10/1999 |
| K991648 | RESPIRONICS, INC. | REUSABLE CONTOUR II NASAL MASK | 05/28/1999 |
| K142554 | Respironics, Inc. | Revolution Full Face Mask | 01/09/2015 |
| K121631 | RESPIRONICS, INC. | SIMPLE T NASAL MASK | 10/05/2012 |
| K151120 | RESPIRONICS, INC. | Simple T Pediatric Nasal Mask | 04/15/2016 |
| K140268 | RESPIRONICS, INC. | SIMPLE T YOUTH NASAL MASK | 10/20/2014 |
| K961626 | RESPIRONICS, INC. | SOLO CPAP SYSTEM | 07/18/1996 |
| K002465 | RESPIRONICS, INC. | SPECTRUM 2 REUSABLE FULL FACE MASK, MODEL 1004884 AND 1004876 | 09/08/2000 |
| K961915 | RESPIRONICS, INC. | SPECTRUM REUSABLE FULL FACE MASK - SIZE PETITE, SMALL, MEDIUM, LARGE | 08/15/1996 |
| K140980 | RESPIRONICS, INC. | TI NASAL MASK | 02/10/2015 |
| K110405 | RESPIRONICS, INC. | TRUBLUE NASAL MASK | 06/06/2011 |
| K201439 | Respironics, Inc. | Ventilator, Non-continuous (Respirator) | 09/25/2020 |
| K993433 | RESPIRONICS, INC. | VIRTUOSO LX SMART CPAP SYSTEM | 10/27/1999 |
| K953930 | RESPIRONICS, INC. | VIRTUOSO SMART CPAP SYSTEM | 09/30/1996 |
| K962203 | RESPIRONICS, INC. | WHISPER SWIVEL II EXHALATION PORT | 12/05/1996 |
| K143700 | Salter Labs | CPAP Cannulaide | 08/05/2015 |
| K040202 | SALTER LABS | SALTER LABS CPAP HIGH FLOW CANNULA SYSTEM | 03/04/2005 |
| K131502 | SEATTLE CHILDRENS HOSPITAL | SEATTLE - PAP | 10/11/2013 |
| K984254 | SENSORMEDICS CORP. | INFANT FLOW NCPAP MASKS | 02/24/1999 |
| K031745 | SENSORMEDICS CORP. | INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION | 02/13/2004 |
| K974303 | SENSORMEDICS CORP. | INFANT FLOW SYSTEM | 01/30/1998 |
| K991972 | SENSORMEDICS CORP. | INFANT FLOW SYSTEM | 08/13/1999 |
| K031883 | SENSORMEDICS CORP. | LYRA NASAL MASK | 08/25/2003 |
| K012034 | SENSORMEDICS CORP. | MODIFICATION TO: SIPAP INFANT NASAL CPAP CIRCUIT | 07/24/2001 |
| K022192 | SENSORMEDICS CORP. | PEGASUS NASAL CPAP SYSTEM | 01/24/2003 |
| K150685 | SKY WISE MEDICAL INSTRUMENT (SHEN ZHEN) CO., LTD. | Skynector CPAP Mask | 08/24/2015 |
| K962713 | SLEEPNET CORPORATION | DPAP STEALTH SLEEPNET MODEL NUMBER 84000 | 10/23/1996 |
| K121321 | SLEEPNET CORPORATION | HARD SHELL VENTED NASAL MASK | 11/30/2012 |
| K203601 | Sleepnet Corporation | Innova Nasal Non-Vented Mask | 04/30/2021 |
| K211274 | Sleepnet Corporation | iQ 2 Nasal Mask, Phantom 2 Nasal Mask | 01/10/2022 |
| K241469 | Sleepnet Corporation | iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask | 06/15/2024 |
| K021534 | SLEEPNET CORPORATION | IQ NASAL MASK, MODEL 50160 REV. D | 07/02/2002 |
| K993269 | SLEEPNET CORPORATION | IQ NASAL MASK, MODEL P/N 50160 | 10/27/1999 |
| K102317 | SLEEPNET CORPORATION | IQ VENTILATION NASAL MASK | 05/17/2011 |
| K121692 | SLEEPNET CORPORATION | MINIME 2 NASAL MASK | 11/05/2012 |
| K013306 | SLEEPNET CORPORATION | MINIME NASAL MASK, MODEL P/N 50220 | 11/02/2001 |
| K090935 | SLEEPNET CORPORATION | MINIME PEDIATRIC MASK | 07/01/2009 |
| K190254 | Sleepnet Corporation | Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask | 07/05/2019 |
| K241661 | Sleepnet Corporation | Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented Mask | 07/10/2024 |
| K241830 | Sleepnet Corporation | Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask | 10/18/2024 |
| K120463 | SLEEPNET CORPORATION | MOJO, VERASEAL | 07/27/2012 |
| K060273 | SLEEPNET CORPORATION | SLEEPNET MOJO FULL FACE MASK -SMALL, MODEL NO. 53835, MEDIUM ,MODEL NO.53836,LARGE,MODEL NO. 53837 | 05/02/2006 |
| K953697 | SLEEPNET CORPORATION | THE IMS DPAP MASK, IMS MODEL NUMBER 82000 | 06/13/1996 |
| K172335 | snapCPAP | Bleep DreamPort | 03/30/2018 |
| K180388 | Somnetics International, Inc. | Transcend 365 miniCPAP System | 11/30/2018 |
| K132127 | SOMNETICS INTERNATIONAL, INC. | TRANSCEND AUTO | 10/17/2013 |
| K141152 | STEVENSON INDUSTRIES, INC. | ADVANTAGE | 10/17/2014 |
| K992384 | STEVENSON INDUSTRIES, INC. | CPAP/PRO CPAP INTERFACE | 12/01/1999 |
| K042294 | SUITER ENTERPRISES, INC. | SLUMBERGEAR(TM), MODEL MULTIPLE (004, 005, 005, 007) | 09/10/2004 |
| K032056 | SUNRISE MEDICAL | BILEVEL CPAP, MODEL 9055 SERIES | 02/20/2004 |
| K043282 | SUNRISE MEDICAL | DEVILBISS AUTOADJUST, MODEL 9054 SERIES | 02/11/2005 |
| K082209 | SUNRISE MEDICAL | DEVILBISS DV5M SMARTLINK SYSTEM | 10/28/2008 |
| K071689 | SUNRISE MEDICAL | DEVILBISS INTELLIPAP MODEL DV 5 SERIES | 09/07/2007 |
| K091919 | SUNRISE MEDICAL | DEVILBISS INTELLIPAP/SLEEPCUBE BILEVEL S/ST | 09/28/2009 |
| K042455 | SUNRISE MEDICAL | DEVILBISS NASAL CPAP MASK, 9354 SERIES | 01/14/2005 |
| K011229 | SUNRISE MEDICAL HHG, INC. | DEVILBISS 9000 SERIES CPAP, MODEL 9001 | 07/11/2001 |
| K203347 | Suzhou Yuyue Medical Technology Co., Ltd. | Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03 Full Face Mask, YN-02 Nasal Mask, YN-03 Nasal Mask, YP-01 Nasal Pillow Mask | 07/02/2021 |
| K192177 | SysMed (China) Co., Ltd | SysMed S/T | 11/25/2020 |
| K012207 | TIARA MEDICAL SYSTEMS, INC. | ADVANTAGE NASAL MASK, SMALL, ADVANTAGE NASAL MASK. REGULAR, MODELS TMS-2520, TMS 2530 | 07/23/2001 |
| K992192 | TIARA MEDICAL SYSTEMS, INC. | AIRPILOTMASK, MODEL TMS-900 | 05/12/2000 |
| K031935 | TIARA MEDICAL SYSTEMS, INC. | TIARA MEDICAL SYSTEMS ADVANTAGE II NASAL MASK, MODELS TMS-2520 AND TMS-2530 | 03/03/2004 |
| K051583 | TIARA MEDICAL SYSTEMS, INC. | TIARA SNAPP X SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030, TMS- 3040, TMS-3050 | 11/04/2005 |
| K964092 | TIARA MEDICAL SYSTEMS, INC. | TMS COMFORT SERIES NASAL CPAP MASK | 07/31/1997 |
| K043382 | TIARA MEDICAL SYSTEMS, INC. | TMS FULL ADVANTAGE FULL FACE MASK, MODELS TMS-2820, TMS-2830, TMS-2840 | 01/19/2005 |
| K034053 | TIARA MEDICAL SYSTEMS, INC. | TMS SNAPP SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030 & TMS-3040 | 06/24/2004 |
| K031470 | TYCO HEALTHCARE NANCY | PURITAN BENNETT, GOODKNIGHT 420 EVOLUTION, MODEL M-113903-US | 06/05/2003 |
| K020886 | TYCO HEALTHCARE NANCY | PURTIAN BENNETT, GOOD KNIGHT 420G MODEL M-113900-US; PURTAN BENNETT, GOODKNIGHT 420S MODEL M-113903-US | 11/01/2002 |
| K102625 | VEGA TECHNOLOGIES, INC. | VEGA CPAP SYSTEM/HEATED HUMIDIFIER, MODEL CP-03 | 06/10/2011 |
| K040726 | VENTLAB CORP. | VENTLAB NASAL CPAP CANNULA | 06/03/2004 |
| K071069 | VIASYS SLEEP SYSTEMS, LLC. | MINI CPAP DEVICE AND HUMIDIFIER ACCESSORY | 06/12/2007 |
| K051559 | VITAL SIGNS COLORADO, INC. | IMASK, MODELS 100, 200 AND 300 | 07/08/2005 |
| K001553 | VITAL SIGNS, INC. | BREAS PV 100 CPAP SYSTEM | 08/03/2000 |
| K030985 | VITAL SIGNS, INC. | BREAS PV 10I CPAP SYSTEM, MODEL PV 10I | 10/15/2003 |
| K041309 | VITAL SIGNS, INC. | IMASK TM | 06/30/2004 |
| K981744 | W. KEITH THORNTON, D.D.S. | COMBINATION TOA WITH NASAL MASK HOLDER AND UNIVERSAL NASAL MASK HOLDER | 10/14/1998 |
| K110884 | WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG | EASYFIT SILKGEL NASAL MASK | 07/12/2011 |
| K102515 | WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG | NP15 | 03/11/2011 |
| K061653 | WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG | SOYALA FULL FACE MASK | 11/09/2006 |
| K073673 | WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG | SOYALA FULL FACE MASK GEL VENTED | 03/28/2008 |
| K081014 | WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG | SOYALA GEL VENTED | 05/09/2008 |
| K112167 | WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG | SOYALA SILKGEL FULL FACE MASK | 11/16/2011 |
| K060405 | WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG | SOYALA, SOYALA BLUE | 06/21/2006 |
| K071163 | WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG | WEINMANNCOMFORT 2, MODEL WM 27600 AND WEINMANNAQUA, MODEL WM 27603 | 07/18/2007 |
| K072009 | WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG | WEINMANNCOMPACT, MODEL WM 27380; WEINMANNCLICK2, MODEL WM 27340 | 12/14/2007 |
| K243023 | Wellell Inc. | WiZARD 520 Full Face Mask | 05/23/2025 |
| K020641 | WORLDWIDE MEDICAL TECHNOLOGIES, LLC | SPIRITUS(TM) RESPIRATORY SYSTEM #SRS 001 | 10/29/2002 |
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