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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
K200565 |
ResMed Corp |
Galapogos |
01/17/2021 |
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 |
K203126 |
ResMed Pty Ltd |
S10 Kirra |
12/18/2020 |
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 |
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 |
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 |
K020641 |
WORLDWIDE MEDICAL TECHNOLOGIES, LLC |
SPIRITUS(TM) RESPIRATORY SYSTEM #SRS 001 |
10/29/2002 |