Ventilator, Non-Continuous (Respirator)
FDA product code BZD · 437 cleared devices
Class 2
Anesthesiology
- Regulation
- 21 CFR 868.5905
- Review panel
- AN
- Implant
- No
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1977-08-04 – 2026-09-25
BZD
2007-09-12
BZD
2007-09-10
SANDMAN INTRO
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BZD
2007-09-07
DEVILBISS INTELLIPAP MODEL DV 5 SERIES
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BZD
2007-07-18
WEINMANNCOMFORT 2, MODEL WM 27600 AND WEINMANNAQUA, MODEL WM 27603
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BZD
2007-07-13
RESTRAXX DATA CENTRE, MODEL R10
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BZD
2007-07-10
VPAP AUTO WITH H3I
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BZD
2007-06-12
MINI CPAP DEVICE AND HUMIDIFIER ACCESSORY
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BZD
2007-05-04
APEX MEDICAL XT1 CPAP, MODEL 9S-005
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BZD
2007-04-30
TWILIGHT FULL FACE MASK
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BZD
2007-04-06
KNIGHTCONTROL REMOTE CONTROL, MODEL M-114700-US
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BZD
2007-03-09
REMSTAR AFLEX CPAP SYSTEM
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BZD
2007-02-23
CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235
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BZD
2007-02-02
MIRAGE QUATTRO FULL FACE MASK
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BZD
2007-02-02
MIRAGE LIBERTY FULL FACE MASK
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BZD
2007-01-22
BREAS ISLEEP 20I
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BZD
2006-12-22
OPUS HC482 DIRECT NASAL MASK
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BZD
2006-11-09
SOYALA FULL FACE MASK
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BZD
2006-09-08
VPAP MALIBU WITH H2I
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BZD
2006-09-05
INVACARE'S TWILIGHT II NASAL MASKS
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BZD
2006-08-29
FLEXIFIT HC432 FULL FACE MASK
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BZD
2006-08-18
ISLEEP BY BREAS, MODELS ISLEEP 10, ISLEEP 20.
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BZD
2006-08-17
RESPCARE HYBRID AV MASK
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BZD
2006-08-11
BREATHX NASAL PILLOW AND MASK SYSTEM, MODEL 011-0003
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BZD
2006-07-20
PRESTIGE CPAP FLOW GENERATOR WITH PRESTIGE HUMIDIFIER
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BZD
2006-07-14
MASKMEDIC CONCEPT NASAL MASK
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BZD
2006-06-23
BREAS ISLEEP 20+
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BZD
2006-06-23
BIPAP PLUS M-SERIES BI-LEVEL SYSTEM
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BZD
2006-06-21
SOYALA, SOYALA BLUE
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BZD
2006-05-02
SLEEPNET MOJO FULL FACE MASK -SMALL, MODEL NO. 53835, MEDIUM ,MODEL NO.53836,LARGE,MODEL NO. 53837
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BZD
2006-02-15
COMFORTLITE NASAL MASK
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BZD
2006-02-03
RES TRAXX DATA CENTER
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BZD
2006-01-04
TREND 200 CPAP DEVICE, MODEL 5CP201; TRENDSET PC SOFTWARE, MODEL TRENDSET
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BZD
2005-12-16
BREATHEX OMEGA CPAP DEVICE, MODEL 322
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BZD
2005-12-07
UTOPIA
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BZD
2005-11-17
AIRLIFE NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE (NCPAP) SYTEM DRIVER
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BZD
2005-11-04
TIARA SNAPP X SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030, TMS- 3040, TMS-3050
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BZD
2005-10-28
RESPCARE FACE MASK
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BZD
2005-10-20
M-SERIES PRO CPAP SYTEM
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BZD
2005-08-03
AIRLIFE INFANT NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM
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BZD
2005-07-15
RES TRAXX DATA CENTER
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BZD
2005-07-08
IMASK, MODELS 100, 200 AND 300
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BZD
2005-06-15
BIPAP AUTO
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BZD
2005-06-13
GOODKNIGHT 425ST
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BZD
2005-05-25
CPAP HUMIDIFIER, MODEL HC238JHU
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BZD
2005-05-10
RESSCAN
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BZD
2005-05-10
PIONEER U121 SERIES CPAP
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BZD
2005-05-04
IT NASAL MASK
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BZD
2005-03-16
ULTRA MIRAGE II MASK
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BZD
2005-03-09
AURA CPAP SYSTEM
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BZD
2005-03-04
SALTER LABS CPAP HIGH FLOW CANNULA SYSTEM
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BZD
2005-03-01
RESMED MERIDIAN MASK
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BZD
2005-02-11
DEVILBISS AUTOADJUST, MODEL 9054 SERIES
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BZD
2005-01-28
BIPAP PRO 2 BI-LEVEL SYSTEM WITH BI-FLEX
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BZD
2005-01-19
TMS FULL ADVANTAGE FULL FACE MASK, MODELS TMS-2820, TMS-2830, TMS-2840
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BZD
2005-01-14
DEVILBISS NASAL CPAP MASK, 9354 SERIES
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BZD
2004-10-08
MIRAGE SWIFT
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BZD
2004-09-10
SLUMBERGEAR(TM), MODEL MULTIPLE (004, 005, 005, 007)
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BZD
2004-09-08
AURA CPAP PATIENT INTERFACE
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BZD
2004-08-31
HC604 CPAP HUMIDIFIER
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BZD
2004-07-30
APEX MEDICAL CPAP MODEL 9S-003
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BZD
2004-07-22
GOODKNIGHT 425, MODELM-114500-00
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BZD
2004-07-15
RESMED HOSPITAL FULL FACE MASK
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BZD
2004-07-01
RESMED S8 PIONEER CPAP SYSTEM
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BZD
2004-06-30
IMASK TM
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BZD
2004-06-30
GUARDIAN NEONATE CPAP/HUMIDIFICATION SYSTEM
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BZD
2004-06-24
TMS SNAPP SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030 & TMS-3040
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BZD
2004-06-10
CPAP HUMIDIFIER, MODEL HC234 (AND RELATED ACCESSORIES)
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BZD
2004-06-09
HOFFRICHTER TREND 110 CPAP DEVICE WITH AQUATREND III CPAP HUMIDIFIER ACCESSORY FOR TREND
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BZD
2004-06-03
RESCONTROL II
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BZD
2004-06-03
VENTLAB NASAL CPAP CANNULA
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BZD
2004-05-05
REMSTAR AUTO WITH C-FLEX CPAP SYSTEM
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BZD
2004-05-05
FLEXIFIL SERIES HC431 FULL FACE MASK, MODEL HC431A
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BZD
2004-05-05
RESCAN
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BZD
2004-04-22
OXYGEN DIVERTER VALVE
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BZD
2004-04-02
RESMED HOSPITAL NASAL MASK
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BZD
2004-03-12
INVACARE POLARIS EX CPAP, MODEL ISP3000
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BZD
2004-03-10
RESMED S8 PRIME CPAP SYSTEM
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BZD
2004-03-10
S7 ELITE CPAP SYSTEM WITH SOMNOTRAXX SYSTEM; AUTOSET SPIRIT CPAP SYSTEM WITH SOMNOTRAXX SYSTEM
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BZD
2004-03-04
BIPAP PRO 2 BI-LEVEL SYSTEM
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BZD
2004-03-03
TIARA MEDICAL SYSTEMS ADVANTAGE II NASAL MASK, MODELS TMS-2520 AND TMS-2530
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BZD
2004-02-20
BILEVEL CPAP, MODEL 9055 SERIES
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BZD
2004-02-19
C2 NASAL MASK
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BZD
2004-02-13
INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION
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BZD
2004-02-04
APEX MEDICAL CPAP RT 21XX
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BZD
2004-01-14
ORACLE ORAL MASK, MODEL HC451A
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BZD
2003-12-04
MIRAGE ACTIVA MASK
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BZD
2003-12-01
MULTI-STRAP FULL FACE MASK
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BZD
2003-10-24
NASAL JACKS MASK
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BZD
2003-10-16
AUTOSET SPIRIT SYSTEM
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BZD
2003-10-15
BREAS PV 10I CPAP SYSTEM, MODEL PV 10I
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BZD
2003-09-09
ARABELLA NCPAP MASKS
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BZD
2003-08-25
LYRA NASAL MASK
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BZD
2003-08-19
MIRAGE VISTA MASK
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BZD
2003-08-15
VPAP III
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BZD
2003-07-23
HOFFRICHTER VECTOR, VECTOR PLUS, VECTOR BI-VEVEL, VECTOR BI-LEVEL PLUS, SCALAR, SCALAR PLUS; CPAP WITH HUMIDIFIER OPTION
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BZD
2003-07-02
S7 ELITE AND AUTOSET SPIRIT CPAP SYSTEMS WITH RESLINK
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BZD
2003-06-24
MODIFICATION TO REMSTAR AUTO CPAP SYSTEM
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BZD
2003-06-12
SINGLE USE ORAL MASK, MODEL HC455A
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BZD
2003-06-12
FISHER & PAYKEL HEALTHECARE ORACLE ORAL MASK
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BZD
2003-06-05
PURITAN BENNETT, GOODKNIGHT 420 EVOLUTION, MODEL M-113903-US
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