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Respironics, Inc.

172 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
AF531 Oro-Nasal SE Face Mask (K243394)Respironics, Inc.2024-12-30
Therapy Mask 3100 NC/SP (K231313)Respironics, Inc.2023-07-28
DreamWear Silicone Pillows Mask (K210844)Respironics, Inc.2021-08-24
Magneto Nasal Mask (K210386)Respironics, Inc.2021-07-12
Sleepware G3 (K202142)Respironics, Inc.2020-10-29
Ventilator, Non-continuous (Respirator) (K201439)Respironics, Inc.2020-09-25
DreamStation 2 System, DreamStation 2 Advanced System (K200480)Respironics, Inc.2020-07-10
Care Orchestrator Essence (K183226)Respironics, Inc.2019-10-18
SomnaPatch (K183625)Respironics, Inc.2019-10-18
Trilogy Evo (K181166)Respironics, Inc.2019-07-18
Trilogy Evo Universal (K181170)Respironics, Inc.2019-07-18
Care Orchestrator (K181053)Respironics, Inc.2019-01-04
Care Cycle Connect Application (K161411)Respironics, Inc.2017-02-17
Simple T Pediatric Nasal Mask (K151120)Respironics, Inc.2016-04-15
Sapphire (K152356)Respironics, Inc.2016-01-08
AF541 SE Full Face Mask (K150638)Respironics, Inc.2015-09-18
AF541 EE Full Face Mask (K150639)Respironics, Inc.2015-09-18
Sleepware G3 (K142988)Respironics, Inc.2015-03-16
TI NASAL MASK (K140980)Respironics, Inc.2015-02-10
Revolution Full Face Mask (K142554)Respironics, Inc.2015-01-09
RESPIRONICS REUSABLE HEATED TUBING (K140424)Respironics, Inc.2014-11-14
SIMPLE T YOUTH NASAL MASK (K140268)Respironics, Inc.2014-10-20
BRONCHOSCOPY ELBOW (K132168)Respironics, Inc.2013-11-20
REMSTAR AUTO A-FLEX HT (K131982)Respironics, Inc.2013-10-18
SOMNOLYZER 24X7 (K131994)Respironics, Inc.2013-10-17
REMSTAR SE (K130077)Respironics, Inc.2013-05-21
KANGAROO NASAL MASK (K122847)Respironics, Inc.2013-03-06
RESPIRONICS SIMPLYCLEAR DEVICE (K122111)Respironics, Inc.2012-12-31
COUGHASSIST T70 DEVICE (K121955)Respironics, Inc.2012-12-14
BIPAP A 40 VENTILATORY SUPPORT SYSTEM (K121623)Respironics, Inc.2012-12-14
REMSTAR SE (K122769)Respironics, Inc.2012-10-09
SIMPLE T NASAL MASK (K121631)Respironics, Inc.2012-10-05
PERFORMAX PEDIATRIC EE TOTAL FACE MASK (K120562)Respironics, Inc.2012-07-17
PERFORMAX PEDIATRIC SE TOTAL FACE MASK (K120639)Respironics, Inc.2012-07-10
SIMPLE T NASAL MASK (K120145)Respironics, Inc.2012-03-30
BIPAP A 30 VENTILATORY SUPPORT SYSTEM (K113053)Respironics, Inc.2012-02-01
REMSTAR AUTO A-FLEX HT (K113068)Respironics, Inc.2011-12-16
SIMPLYGO PORTABLE OXYGEN CONCENTRATOR (K111885)Respironics, Inc.2011-11-04
TRILOGY SERIES VENTILATOR WITH OXIMETRY (K111610)Respironics, Inc.2011-10-14
TRUBLUE NASAL MASK (K110405)Respironics, Inc.2011-06-06
RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS (K110398)Respironics, Inc.2011-06-01
V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS (K102985)Respironics, Inc.2011-04-05
PERFORMAX TOTAL FACE MASK (K103395)Respironics, Inc.2011-03-24
BIPAP AVAPS VENTILATORY SUPPORT SYSTEM (K102465)Respironics, Inc.2011-03-24
GOLIFE NASAL MASK (K110008)Respironics, Inc.2011-02-17
GOLIFE NASAL MASK (K102502)Respironics, Inc.2010-12-22
ESPRIT VENTILATOR WITH AF531 SE FULL FACE MASK (K101129)Respironics, Inc.2010-09-16
BIPAP SYNCHRONY 2 WITH AF531 FULL FACE MASK (K101130)Respironics, Inc.2010-09-02
TRILOGY 202 VENTILATOR (K093905)Respironics, Inc.2010-05-12
TRILOGY 200 VENTILATOR (K093416)Respironics, Inc.2010-01-29
BIPAP AVAPS VENTILATORY SUPPORT SYSTEM (K092818)Respironics, Inc.2010-01-22
BIPAP SYNCHRONY 2 (K092043)Respironics, Inc.2009-08-05
OMNI 5 TOTAL O2 DELIVERY SYSTEM (K091028)Respironics, Inc.2009-07-23
RESPIRONICS SLEEPEASY CPAP SYSTEM (K091112)Respironics, Inc.2009-05-15
COMFORTLITE NASAL MASK (K082558)Respironics, Inc.2009-03-25
ENTERAL ONLY EXTENSION SET (K082654)Respironics, Inc.2008-11-25
GOLOX-93 (K081779)Respironics, Inc.2008-09-19
HOMELOX (K081206)Respironics, Inc.2008-07-28
RESPIRONICS GOLOX (K072723)Respironics, Inc.2008-03-20
REMSTAR PRO M-SERIES CPAP & HEATED HUMIDIFIER SYSTEM (K072996)Respironics, Inc.2007-12-27
BIPAP AUTOSV (K063540)Respironics, Inc.2007-02-22
BIPAP SYNCHRONY (K063533)Respironics, Inc.2007-02-20
ACTICAL (K060919)Respironics, Inc.2006-09-22
VITALSENSE XHR (K061870)Respironics, Inc.2006-08-31
SMARTMONITOR 2PS (K061256)Respironics, Inc.2006-08-02
L4 OXYGEN CONCENTRATOR (K061261)Respironics, Inc.2006-06-28
BIPAP PLUS M-SERIES BI-LEVEL SYSTEM (K061034)Respironics, Inc.2006-06-23
COMFORTLITE NASAL MASK (K053352)Respironics, Inc.2006-02-15
STARDUST II (K052573)Respironics, Inc.2005-12-13
M-SERIES PRO CPAP SYTEM (K052110)Respironics, Inc.2005-10-20
ACTIHEART (K052489)Respironics, Inc.2005-09-27
BIPAP AUTO (K050759)Respironics, Inc.2005-06-15
PLIX (K050414)Respironics, Inc.2005-04-11
MILLENNIUM M10 OXYGEN CONCENTRATOR, MODEL M10600; WITH OPI, MODEL M10605 (K043006)Respironics, Inc.2005-02-11
BIPAP PRO 2 BI-LEVEL SYSTEM WITH BI-FLEX (K043607)Respironics, Inc.2005-01-28
EOCD (K041568)Respironics, Inc.2004-07-21
STARDUST II, MODEL 1011176 (K021845)Respironics, Inc.2004-05-20
REMSTAR AUTO WITH C-FLEX CPAP SYSTEM (K041010)Respironics, Inc.2004-05-05
ALICE 5 (K040595)Respironics, Inc.2004-03-18
BIPAP PRO 2 BI-LEVEL SYSTEM (K032834)Respironics, Inc.2004-03-04
C2 NASAL MASK (K033759)Respironics, Inc.2004-02-19
RESPIRONICS CUSTOM I ORAL APPLIANCE (K033822)Respironics, Inc.2004-02-06
RESPIRONICS CUSTOM II ORAL APPLIANCE (K033823)Respironics, Inc.2004-02-06
HEEL SNUGGLER, MODEL 99047 (K040044)Respironics, Inc.2004-01-27
ESPRIT VENTILATOR, MODEL V1000 (K034040)Respironics, Inc.2004-01-21
SMARTMONITOR 2 PROFESSIONAL SERIES (PS) (K032403)Respironics, Inc.2003-10-27
BIPAP HARMONY VENTILATORY SUPPORT SYSTEM (K031656)Respironics, Inc.2003-07-30
MODIFICATION TO REMSTAR AUTO CPAP SYSTEM (K031460)Respironics, Inc.2003-06-24
H2 HEATED HUMIDIFIER (K030090)Respironics, Inc.2003-01-24
IMAGE3 SE DISPOSABLE FULL FACE MASK (K023135)Respironics, Inc.2003-01-03
REMSTAR PRO WITH C-FLEX CPAP SYSTEM (K021861)Respironics, Inc.2002-06-19
BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM WITH BI-FLEX (K020777)Respironics, Inc.2002-03-20
RESPIRONICS HEATED HUMIDIFIER (K012633)Respironics, Inc.2002-02-28
REMSTAR AUTO CPAP SYSTEM (K012554)Respironics, Inc.2002-01-29
BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM (K012323)Respironics, Inc.2001-12-20
BIPAP PRO BI-LEVEL SYSTEM (K011714)Respironics, Inc.2001-06-28
REMSTAR PLUS CPAP SYSTEM (K010263)Respironics, Inc.2001-03-29
RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER (K010052)Respironics, Inc.2001-03-19
REMVIEW SLEEP RECORDER, MODEL 320 (K003499)Respironics, Inc.2001-02-09
RESPIRONICS SILHOUETTE NASAL MASK, MODELS 1003224 AND 1003223 (K000705)Respironics, Inc.2000-09-08
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