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BZD

461 FDA 510(k) clearances · Product code

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RecordFirmDate
AIRFIT N10 (K132887)Resmed, Ltd.2013-12-20
K SERIES CPAP SYSTEMS (K131702)Curative Medical, Inc.2013-12-06
3B RESMART CPAP AND AUTO CPAP, BMC RESMART CPAP AND AUTO CPAP (K132967)3B Medical, Inc.2013-12-06
BRONCHOSCOPY ELBOW (K132168)Respironics, Inc.2013-11-20
SWIFT AIR (K132013)Resmed, Ltd.2013-10-21
REMSTAR AUTO A-FLEX HT (K131982)Respironics, Inc.2013-10-18
TRANSCEND AUTO (K132127)Somnetics International, Inc.2013-10-17
NASAL COMFORT FREEDOM (K130686)Lakeview Sleep Center2013-10-16
SEATTLE - PAP (K131502)Seattle Childrens Hospital2013-10-11
BESTFIT2 NASAL MASK (K130663)Curative Medical, Inc.2013-09-27
3B RESMART CPAP AND AUTO CPAP SYSTEMS, BMC RESMART CPAP AND AUTO CPAP SYSTEMS (K131707)3B Medical, Inc.2013-08-22
WIZARD 230 NASAL PILOW MASK (K121642)Apex Medical Corp.2013-06-06
F&P SIMPLUS FULL FACE MASK (K130328)Fisher & Paykel Healthcare Limited2013-06-05
SLEEPWEAVER ANEW FULL FACE SOFT CLOTH PAP MASK (K130481)Circadiance, LLC2013-05-24
REMSTAR SE (K130077)Respironics, Inc.2013-05-21
BREATHE CPAP SYSTEM (K130037)Breathe Technologies, Inc.2013-05-17
SWIFT FX NANO (K123789)Resmed, Ltd.2013-03-29
FACEFIT AND FACEFIT PORTED NON-INVASIVE VENTILATION MASKS (K121747)Intersurgical Incorporated2013-03-14
K SERIES CPAP SYSTEMS (K123897)Curative Medical, Inc.2013-03-13
KANGAROO NASAL MASK (K122847)Respironics, Inc.2013-03-06
QUATTRO AIR (K123979)Resmed, Ltd.2013-02-27
ZI BLOWER (K121374)Deshum Medical2013-02-22
APEX MEDICAL XT AUTO CPAP WITH COMPLIANCE IMPROVEMENT ALGORITHM 9S-005720 (K112079)Apex Medical Corp.2012-12-06
HARD SHELL VENTED NASAL MASK (K121321)Sleepnet Corporation2012-11-30
MINIME 2 NASAL MASK (K121692)Sleepnet Corporation2012-11-05
TAP PAP NASAL PILLOW MASK (K122350)Airway Management, Inc.2012-11-01
GEO (K121705)Resmed, Ltd.2012-10-23
REMSTAR SE (K122769)Respironics, Inc.2012-10-09
SIMPLE T NASAL MASK (K121631)Respironics, Inc.2012-10-05
ESON NASAL MASK (K121597)Fisher & Paykel Healthcare Limited2012-10-02
MOJO, VERASEAL (K120463)Sleepnet Corporation2012-07-27
PERFORMAX PEDIATRIC EE TOTAL FACE MASK (K120562)Respironics, Inc.2012-07-17
HSINER CPAP SILICONE NASAL MASK SIZE XS/PETITE HSINER NASAL PILLOW MASK HSINER INFANT CPAP CANNULA (K120920)Hsiner Company2012-07-16
K SERIES CPAP SYSTEM WITH HEATED HUMIDIFER (K120285)Curative Medical, Inc.2012-07-02
VPAP ADAPT (K113801)Resmed Corp2012-05-25
APEX MEDICAL ICH CPAP SERIES (9S-007XXX) (K120035)Apex Medical Corp.2012-05-16
RESMART CPAP, RESMART AUTO-CPAP AND RESMART HUMIDIFIER (K110629)3B Products, Inc.2012-04-27
SLEEPWEAVER ELAN NASAL CPAP MASK (K120757)Circadiance, LLC2012-04-24
EASYCARE TX SYSTEM (CONNEXUNS) (K113780)Resmed, Ltd.2012-04-20
SIMPLE T NASAL MASK (K120145)Respironics, Inc.2012-03-30
PILAIRO NASAL PILLOWS MASK (K120027)Fisher & Paykel Healthcare Limited2012-02-23
3B WILLOW (K112271)3B Products, LLC2012-02-16
MIRAGE QUATTRO (K113127)Resmed, Ltd.2012-01-06
REMSTAR AUTO A-FLEX HT (K113068)Respironics, Inc.2011-12-16
SWIFT FX BELLA (K112489)Resmed, Ltd.2011-12-07
DEVILBISS INTELLIPAP / SLEEPCUBE AUTO BILEVEL (K112220)Devilbiss Healthcare, LLC2011-11-22
TASMAN (K112393)Resmed, Ltd.2011-11-16
SOYALA SILKGEL FULL FACE MASK (K112167)Weinmann Gerate Fur Medizin GmbH + Co. KG2011-11-16
3B FLEX-LITE (K103434)3B Products, LLC2011-10-13
BABI PLUS INFANT NASAL CANNULA SYSTEM (K110471)A Plus Medical2011-10-07
INFOSEND GSM (K110316)Fisher & Paykel Healthcare, Ltd.2011-08-19
BABI*PLUS PRESSURE RELIEF MANIFOLD - 10CM H20, 12.5CM H20, 15CM H20 (K110383)A Plus Medical2011-08-01
EASYFIT SILKGEL NASAL MASK (K110884)Weinmann Gerate Fur Medizin GmbH + Co. KG2011-07-12
S8 ASPEN WITH H4I PLUS (K111148)Resmed Corp2011-06-30
VEGA CPAP SYSTEM/HEATED HUMIDIFIER, MODEL CP-03 (K102625)Vega Technologies, Inc.2011-06-10
TRUBLUE NASAL MASK (K110405)Respironics, Inc.2011-06-06
IQ VENTILATION NASAL MASK (K102317)Sleepnet Corporation2011-05-17
APEX MEDICAL WIZARD SERIES CPAP MASK (K103174)Apex Medical Corp.2011-05-06
NEOPAP SYSTEM (K103410)Childrens Medical Ventures, LLC2011-03-30
ZEST PETITE NASAL MASK (K103786)Fisher & Paykel Healthcare, Ltd.2011-03-24
PERFORMAX TOTAL FACE MASK (K103395)Respironics, Inc.2011-03-24
S9 VPAP ADAPT WITH H5I (K102586)Resmed, Ltd.2011-03-18
MIRAGE MICRO (K110444)Resmed, Ltd.2011-03-16
NP15 (K102515)Weinmann Gerate Fur Medizin GmbH + Co. KG2011-03-11
GOLIFE NASAL MASK (K110008)Respironics, Inc.2011-02-17
S9 VPAP ST WITH H5I (K102513)Resmed, Ltd.2011-01-05
MIRAGE FX (K102746)Resmed, Ltd.2010-12-28
GOLIFE NASAL MASK (K102502)Respironics, Inc.2010-12-22
PIXI PEDIATRIC MASK (K102224)Resmed, Ltd.2010-12-10
FISHER & PAYKEL HEALTHCARE BUBBLE CPAP SYSTEM (K100011)Fisher & Paykel Healthcare, Ltd.2010-10-08
MODEL 300157 CPAP SYSTEM (K100121)Aeiomed, Inc.2010-07-13
MIRAGE MICRO MODEL 16333 (S), 16334 (M&L), 16335 (LW & XL) (K100772)Resmed, Ltd.2010-06-09
BABI PLUS INFANT NASAL CANNULA SYSTEM (K093716)A Plus Medical2010-05-13
F&P ICON SERIES CPAP (K094040)Fisher & Paykel Healthcare, Ltd.2010-04-27
PAP-CAP (K100343)Pur-Sleep, Inc.2010-04-23
PURESOM NASAL MASK-SMALL, PURESOM NASAL MASK-MEDIUM, PURESOM NASAL MASK-LARGE, MODELS 11924-01, 11924-02, 11924-03 (K093124)Cardinal Health 207, Inc.2010-03-10
EASYCARE ONLINE (K093684)Resmed, Ltd.2010-02-26
COMFORTGEL NASAL MASK (K092835)Respironics Inc., Sleep & Home Respiratory Group2010-02-12
NASAL AIRE II PEDIATRIC, MODEL 5 SIZES, MODEL TBD (K090804)Innomed Technologies, Inc./Respcare, Inc.2009-11-05
SLEEPWEAVER NASAL CPAP MASK (K092362)Circadiance, LLC2009-11-02
EASYCARE TX, TX LINK (K092026)Resmed, Ltd.2009-10-02
S8 ASPEN WITH H4I PLUS (K091947)Resmed, Ltd.2009-09-28
DEVILBISS INTELLIPAP/SLEEPCUBE BILEVEL S/ST (K091919)Sunrise Medical2009-09-28
COMFORT TWIN NASAL MASK (K091843)Respironics Inc., Sleep & Home Respiratory Group2009-09-10
COMFORT TWIN NASAL MASK (K091066)Respironics Inc., Sleep & Home Respiratory Group2009-09-03
QUATTRO LT (K091129)Resmed, Ltd.2009-08-03
REMSTAR AUTO A-FLEX (K091319)Respironics Inc., Sleep & Home Respiratory Group2009-08-03
MINIME PEDIATRIC MASK (K090935)Sleepnet Corporation2009-07-01
RESPIRONICS PERFORMAX TOTAL FACE MASK (K091271)Respironics Inc., Sleep & Home Respiratory Group2009-05-29
RESPIRONICS SLEEPEASY CPAP SYSTEM (K091112)Respironics, Inc.2009-05-15
REMSTAR M-SERIES AUTO WITH AFLEX CPAP SYSTEM (K090243)Respironics Inc., Sleep & Home Respiratory Group2009-05-08
MIRAGE ECHO (K090490)Resmed Corp2009-05-06
APEX MEDICAL XT AUTO CPAP 9S-005200 (K083656)Apex Medical Corp.2009-04-22
SWIFT FX (K090244)Resmed, Ltd.2009-04-13
COMFORTLITE NASAL MASK (K082558)Respironics, Inc.2009-03-25
RES TRAXX ONLINE, MODEL: R14 (K083816)Resmed, Ltd.2009-03-20
ZEST NASAL MASK (K083832)Fisher & Paykel Healthcare, Ltd.2009-03-16
REVOLUTIONFULL FACE MASK (K082866)Respironics Inc., Sleep & Home Respiratory Group2009-01-30
VPAP AUTO WITH HUMIDAIRE 3I (K082605)Resmed, Ltd.2009-01-13
S8 ADVANCE (K082979)Resmed, Ltd.2009-01-02
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