Ventilator, Continuous, Facility Use
FDA product code CBK · 493 cleared devices
Class 2
Anesthesiology
- Regulation
- 21 CFR 868.5895
- Review panel
- AN
- Implant
- No
- Life sustaining
- Yes
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1976-09-27 – 2026-05-07
CBK
2010-03-04
CBK
2010-01-29
TRILOGY 200 VENTILATOR
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CBK
2010-01-21
ENDURAVENT-5 VENTILATOR
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CBK
2009-12-18
RESPIRONICS PERFORMAX SE TOTAL FACE MASK
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CBK
2009-12-17
ATLANTIS HYPERBARIC CHAMBER VENTILATOR
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CBK
2009-11-23
MODIFICATION TO IVENT 101
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CBK
2009-11-18
NEWPORT HT70 FAMILY OF VENTILATORS
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CBK
2009-08-13
UNI-VENT-731 SERIES VENTILATORS, MODEL 731EMV+
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CBK
2009-06-15
HAMILTON-C2
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CBK
2009-04-02
PB 840 VENTILATOR SYSTEM WITH LEAK COMPENSATION OPTION, MODEL 840
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CBK
2009-03-18
PULMONETIC SYSTEMS LTV 1200 MR CONDITIONAL VENTILATOR
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CBK
2009-03-16
IVENT101
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CBK
2009-03-13
TRILOGY 100 VENTILATOR
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CBK
2009-03-04
HOSPITAL FULL FACE MASK NON VENTED, MODEL: RT041
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CBK
2009-01-02
NEPTUNE HYPERBARIC VENTILATOR
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CBK
2008-12-29
EVITE XL
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CBK
2008-12-16
NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEM
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CBK
2008-12-10
UNI-VENT 731 SERIES VENTILATORS, MODEL 731, 731EMV
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CBK
2008-11-26
OXYLOG 2000 PLUS SYSTEM (MODEL 5705080), OXYLOG 2000 PLUS BASIC DEVICE (MODEL 5705082)
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CBK
2008-10-31
PB 540 VENTILATOR
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CBK
2008-10-15
HELONTIX VENT
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CBK
2008-10-09
THE ADVANTAGE SERIES NON-VENTED (NV) FULL FACE MASK
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CBK
2008-10-03
ENGSTROM CARESTATION, ENGSTROM PRO
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CBK
2008-09-25
MODIFICATION TO HAMILTON-G5
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CBK
2008-09-22
CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKS
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CBK
2008-08-13
AVEA VENTILATOR
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CBK
2008-06-24
MODIFICATION TO GALILEO GOLD
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CBK
2008-06-09
SERVO-I VENTILATOR SYSTEM MODEL 64 87 800 E4073, HELIOX OPTION, MODEL 6675585
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CBK
2008-05-30
IVENT 2001 MRI CONDITIONAL
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CBK
2008-04-07
CARINA SYSTEM, MODEL 8419350; CARINA BASIC DEVICE, MODEL 5704110
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CBK
2008-02-06
OPTION SMARTCARE FOR EVITAXL,SMARTCARE KIT CAPNO PACKAGE, CO2 SENSOR CAPNOSMART, MODELS 8415941, 8415942, 6871500
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CBK
2008-01-25
MODIFICATION TO AVEA VENTILATOR
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CBK
2008-01-04
INSPIRATION; VENTILATOR SYSTEM, LS VENTILATOR SYSTEM, INFANT VENTILATOR SYSTEM AND INFANT LS VENTILATOR SYSTEM
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CBK
2007-12-18
PERFORMAX SE TOTAL FACE MASK
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CBK
2007-12-13
PURITAN BENNETT LEGENDAIR XL2
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CBK
2007-12-12
ESPRIT VENTILATOR AUTO-TRAK SENSITIVITY OPTION, MODEL V1000
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CBK
2007-11-26
HAMILTON-G5
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CBK
2007-10-18
RAPHAEL COLOR ASV VENTILATOR
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CBK
2007-08-01
PALMTOP VENTILATOR, MODELS PTV-8, PTV-10
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CBK
2007-07-30
ESPRIT VENTILATOR SPEAKING MODE OPTION, MODEL V1000
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CBK
2007-05-17
SLEEPNET MOJO -NV FULL FACE MASK, NON-VENTED
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CBK
2007-02-15
VENTILATOR WITH RESPIRATORY MECHANICS, MODEL 840
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CBK
2007-02-15
SERVO-I VENTILATOR SYSTEM, MODELS 64, 87 AND 800
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CBK
2007-02-07
SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E; NAVA OPTION
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CBK
2006-12-08
GE DATEX-OHMEDA ENGSTROM CARESTATION
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CBK
2006-10-31
OXYLOG 3000
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CBK
2006-09-20
AVEA VENTILATOR
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CBK
2006-08-17
RESPCARE HYBRID NE FACE MASK, MODEL TBD,; DISPOSABLE, MODEL TBD
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CBK
2006-07-28
NEWPORT E500 WAVE VENTILATOR
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CBK
2006-07-17
GALILEO GOLD ASV
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CBK
2006-06-29
MODIFICATION TO I VENT 201
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CBK
2006-06-14
CARINA HOME
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CBK
2006-06-05
GE DATEX-OHMEDA ENGSTROM CARESTATION
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CBK
2006-05-25
LTV 1200 VENTILATOR
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CBK
2006-05-04
AUTOMOBILE LIGHTER POWER CORD
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CBK
2006-04-04
MODEL 840 VENTILATOR WITH PROPORTIONAL ASSIST VENTILATION PLUS SOFTWARE OPTION
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CBK
2006-01-27
IVENT 201
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CBK
2006-01-10
NEWPORT E360 VENTILATOR
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CBK
2006-01-06
RAPHAEL COLOR
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CBK
2005-09-27
GE DATEX-OHMEDA ENGSTROM CARESTATION
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CBK
2005-09-23
MODIFICATION TO: IVENT 201 PORTABLE VENTILATOR
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CBK
2005-09-23
AV-S ANAESTHESIA VENTILATOR
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CBK
2005-07-29
LTV 1000 VENTILATOR
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CBK
2005-07-12
INSPIRATION VENTILATOR SYSTEM
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CBK
2005-07-12
EVITAXL WITH OPTION SMARTCARE
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CBK
2005-07-08
ESPRIT VENTILATOR NEONATAL OPTION, MODEL V1000
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CBK
2005-06-21
GE DATEX-OHMEDA CENTIVA/5 VENTILATOR
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CBK
2005-03-25
GE DATEX-OHMEDA ENGSTROM CARESTATION
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CBK
2004-12-20
MODIFICATION TO: PNEUTON VENTILATOR
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CBK
2004-11-17
IVENT 201 PORTABLE VENTILATOR
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CBK
2004-10-27
GALILEO GOLD
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CBK
2004-10-26
GE DATEX-OHMEDA ENGSTROM CARESTATION
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CBK
2004-09-22
CLARISSA INFANT NCPAP CANNULA
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CBK
2004-09-20
GE DATEX-OHMEDA HELIOX DELIVERY SYSTEM
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CBK
2004-07-29
MODIFICATION TO SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E
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CBK
2004-06-18
ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000
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CBK
2004-06-03
MODIFICATION TO LTV 1000 VENTILATOR/BREATHING CIRCUITS
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CBK
2004-06-02
LPO OPTION FOR DRAGER INTENSIVE CARE VENTILATOR SAVINA
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CBK
2004-04-29
MODIFICATION TO LTV 1000 VENTILATOR
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CBK
2004-03-17
BIRD TBIRD VELA VENTILATOR
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CBK
2004-02-20
SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E
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CBK
2004-01-23
NEWPORT E500 WAVE VENTILATOR
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CBK
2004-01-21
ESPRIT VENTILATOR, MODEL V1000
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CBK
2004-01-16
MODIFICATION TO INSPIRATION VENTILATOR SYSTEM
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CBK
2003-10-22
RAPHAEL
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CBK
2003-10-16
LTV-1000 VENTILATOR
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CBK
2003-10-07
DATEX-OHMEDA 7900 VENTILATOR ENHANCEMENTS
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CBK
2003-06-03
PNEUTON VENTILATOR
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CBK
2003-05-02
HANS RUDOLPH 7500 SERIES REUSABLE ORO-NASAL NIV MASKS
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CBK
2003-01-15
OPTION NIV, MODEL 8414115, UPGRADE KIT NIV, MODEL 8414072
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CBK
2003-01-03
IMAGE3 SE DISPOSABLE FULL FACE MASK
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CBK
2002-12-20
MONSOON CRITICAL CARE JET VENTILATOR AND ACCESSORIES
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CBK
2002-11-22
INSPIRATION VENTILATOR SYSTEM
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CBK
2002-11-06
ESPRIT VENTILATOR WITH RESPIRATORY MECHANICS
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CBK
2002-11-06
BIRD AVEA VENTILATOR
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CBK
2002-09-19
SERVO VENTILATOR SYSTEM, MODEL 64 87 800 E407E
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CBK
2002-08-13
PURITAN-BENNETT 840 VENTILATIOR SYSTEM WITH VOLUME VENTILATION PLUS OPTION
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CBK
2002-08-01
MISTRAL CRITICAL CARE JET VENTILATOR AND ACCESSORIES
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CBK
2002-05-22
AVEA
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CBK
2002-04-22
BIRD TBIRD VELA VENTILATOR
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