FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart C—Monitoring Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—Cardiovascular Therapeutic Devices
CFR Sub-Part
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
BRW
Protector, Dental
1
Product Code
BSF
Absorber, Carbon-Dioxide
1
Product Code
BSJ
Mask, Gas, Anesthetic
1
Product Code
BSK
Cuff, Tracheal Tube, Inflatable
2
Product Code
BSN
Filter, Conduction, Anesthetic
2
Product Code
BSO
Catheter, Conduction, Anesthetic
2
Product Code
BSP
Needle, Conduction, Anesthetic (W/Wo Introducer)
2
Product Code
BSR
Stylet, Tracheal Tube
1
Product Code
BSZ
Gas-Machine, Anesthesia
2
Product Code
BTB
Hook, Ether
1
Product Code
BTC
Bag, Reservoir
1
Product Code
BTK
Strap, Head, Gas Mask
1
Product Code
BTL
Ventilator, Emergency, Powered (Resuscitator)
2
Product Code
BTM
Ventilator, Emergency, Manual (Resuscitator)
2
Product Code
BTO
Tube, Tracheostomy (W/Wo Connector)
2
Product Code
BTP
Dropper, Ether
1
Product Code
BTQ
Airway, Nasopharyngeal
1
Product Code
BTR
Tube, Tracheal (W/Wo Connector)
2
Product Code
BTS
Tube, Bronchial (W/Wo Connector)
2
Product Code
BTT
Humidifier, Respiratory Gas, (Direct Patient Interface)
2
Product Code
BWB
Forceps, Tube Introduction
1
Product Code
BWC
Needle, Emergency Airway
2
Product Code
BWF
Spirometer, Therapeutic (Incentive)
2
Product Code
BWL
Apparatus, Electronanesthesia
3
Product Code
BYD
Condenser, Heat And Moisture (Artificial Nose)
1
Product Code
BYE
Attachment, Breathing, Positive End Expiratory Pressure
2
Product Code
BYF
Mask, Oxygen, Low Concentration, Venturi
1
Product Code
BYG
Mask, Oxygen
1
Product Code
BYH
Drain, Tee (Water Trap)
1
Product Code
BYI
Percussor, Powered-Electric
2
Product Code
BYJ
Unit, Liquid-Oxygen, Portable
2
Product Code
BYK
Tent, Oxygen, Electrically Powered
2
Product Code
BYL
Tent, Oxygen
1
Product Code
BYN
Chair, Posture, For Cardiac And Pulmonary Treatment
1
Product Code
BYO
Bottle, Blow
1
Product Code
BYP
Mouthpiece, Breathing
1
Product Code
BYT
Ventilator, External Body, Negative Pressure, Adult (Cuirass)
2
Product Code
BYW
Device, Rebreathing
1
Product Code
BYX
Tubing, Pressure And Accessories
1
Product Code
BZA
Connector, Airway (Extension)
1
Product Code
BZB
Catheter, Nasal, Oxygen
1
Product Code
BZD
Ventilator, Non-Continuous (Respirator)
2
Product Code
BZE
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
2
Product Code
BZO
Set, Tubing And Support, Ventilator (W Harness)
1
Product Code
K
95
3784
UNICOR, INC. CORRUGATED TUBING
1
Cleared 510(K)
K
95
3785
UNICOR, INC. VENTILATOR HOSES
1
Cleared 510(K)
K
95
2011
PRIMA BREATHING BAGS
1
Cleared 510(K)
K
95
2010
PRIMA VENTILATOR HOSES
1
Cleared 510(K)
K
95
2012
PRIMA CUSTOM ANESTESIA CIRCUIT
1
Cleared 510(K)
K
95
2022
PRIMA VOLUMN VENTILATORSS
1
Cleared 510(K)
K
94
5740
INFANT FLOW SYSTEM
1
Cleared 510(K)
K
94
4531
PRIMA, INC. CORRUGATED TUBING
1
Cleared 510(K)
K
94
2572
VOLUME VENTILATOR
1
Cleared 510(K)
K
94
2569
VENTILATOR HOSE
1
Cleared 510(K)
K
93
5582
TUBE, INHALER OXYGEN
1
Cleared 510(K)
K
93
4753
STAR BREATHING CIRCUITS
1
Cleared 510(K)
K
93
2706
PRECISION MED PRODUCTS LTD. VENTILATOR HOSE
1
Cleared 510(K)
K
93
2712
PRECISION MED PRODUCTS LTD VOLUME VENTILATORS
1
Cleared 510(K)
K
93
2560
VOLUME VENTILATORS
1
Cleared 510(K)
K
93
2563
VENTILATOR HOSES
1
Cleared 510(K)
K
93
2119
CLEVELAND TUBING, INC. VENTILATOR HOSES
1
Cleared 510(K)
K
92
2479
DISPOSABLE ANESTHESIA BREATHING CIRCUIT, MODIFIED
1
Cleared 510(K)
K
92
1510
GAS SAMPLING KIT MODIFICATION
1
Cleared 510(K)
K
91
1328
UNIVERSAL VOLUME VENTILATOR CIRCUIT, MODIFICATION
1
Cleared 510(K)
K
90
3083
NEONATAL VENTILATOR CIRCUIT
1
Cleared 510(K)
K
90
3055
EXTENDED LIFE CIRCUITS
1
Cleared 510(K)
K
90
3404
FLOCARE F
1
Cleared 510(K)
K
89
6439
TUBING FLEXIBLE MEDICAL GAS LOW-PRESSURE
1
Cleared 510(K)
K
89
5853
SECHRIST DISPOSABLE INFANT BREATHING CIRCUIT
1
Cleared 510(K)
K
89
3760
CRITERION I.V. VENTILATOR BREATHING CIRCUIT #1004
1
Cleared 510(K)
K
89
0822
CIRCUIT BREATHING (W CONNECTOR, ADAPTER Y PIECE)
1
Cleared 510(K)
K
89
0011
OXYGEN CONNECTOR AND OXYGEN DELIVERY TUBING
1
Cleared 510(K)
K
88
4525
PEDIATRIC HUMIDIFIER TUBE W/ TEMPERATURE PORT
1
Cleared 510(K)
K
88
2341
QUICK CONNECT T ADAPTOR
1
Cleared 510(K)
K
88
0959
LIFEGUARD GAS SAMPLING LINE FOR MASS SPECTROMETRY
1
Cleared 510(K)
K
88
0637
BAXTER, PHARMASEAL PATIENT GAS SAMPLING LINES
1
Cleared 510(K)
K
87
4559
BABYFLEX PATIENT CIRCUIT
1
Cleared 510(K)
K
87
3900
PORTABLE VENTILATOR PATIENT CIRCUIT
1
Cleared 510(K)
K
87
3927
REUSEABLE BREATHING TUBES
1
Cleared 510(K)
K
86
3756
MODIFIED CRITERION VENTILATOR BREATHING CIRCUIT
1
Cleared 510(K)
K
86
3910
RAINCOAT
1
Cleared 510(K)
K
86
3033
PATIENT GAS SAMPLING KIT/5STAND ALONE VERSIONS
1
Cleared 510(K)
K
86
0659
END TIDAL CO2 SAMPLING CIRCUIT
1
Cleared 510(K)
K
86
1286
GAS SAMPLING KIT
1
Cleared 510(K)
K
86
0880
VENTILATOR CIRCUITS (VARIOUS TYPES)
1
Cleared 510(K)
K
86
0879
DISPOSABLE VENTILATOR CIRCUITS
1
Cleared 510(K)
K
85
0151
L100B UNIVERSAL & L100A NIGHT PATIENT CIRCUIT
1
Cleared 510(K)
K
85
0600
CO-AX VENTILATOR CIRCUIT
1
Cleared 510(K)
K
85
0703
SAF T FLO VENTILATOR TUBING
1
Cleared 510(K)
K
84
4290
L100D PATIENT CIRCUIT DUAL LINE
1
Cleared 510(K)
K
84
3036
PATIENT BREATHING CIRCUIT
1
Cleared 510(K)
K
84
2778
AVATRON UNIVERSAL ADULT VOL. VENTILATOR
1
Cleared 510(K)
K
84
2389
AVATRON DISPOSABLE I.P.P.B. CIRUCIT
1
Cleared 510(K)
K
84
1657
PATIENT TUBING HYTREL SIEMENS-ELEMA
1
Cleared 510(K)
K
84
1722
MASS SPECTROMETER INTERFACE
1
Cleared 510(K)
K
84
1637
THREE PORT SENSOR MANIFOLD
1
Cleared 510(K)
K
84
1378
VENT-WELL VENTILATOR TUBING
1
Cleared 510(K)
K
83
4569
VENTILATORY FREQUENCY MONITOR
1
Cleared 510(K)
K
83
4570
VOLUME VENTILATOR CIRCUIT W/WATER TRAP
1
Cleared 510(K)
K
83
3459
COAXIAL VOL. VENTILATOR CIRCUIT
1
Cleared 510(K)
K
83
2681
UNIVERSAL VOL. VENTILATOR 72 #1626
1
Cleared 510(K)
K
83
0923
TEMP-CHECK ADAPTOR, STRAIGHT CONFIGURA
1
Cleared 510(K)
K
83
0922
TEMP-CHECK ADAPTOR, TEE-CONFIGURATION
1
Cleared 510(K)
K
83
0921
TEMP-CHECK ADAPTOR, Y-CONFIGURATION
1
Cleared 510(K)
K
82
3481
BE #16 - MANIFOLD
1
Cleared 510(K)
K
82
3271
DISPOSABLE ADULT VO. VENTILATOR CIRCUIT
1
Cleared 510(K)
K
82
3479
MODUFLEX NEONATAL VENTILATOR SET
1
Cleared 510(K)
K
82
3287
RESPIRATORY CIRCUIT ADAPTOR
1
Cleared 510(K)
K
82
1064
INSPIRON NEONATAL VENTILATOR CIRCUIT
1
Cleared 510(K)
K
82
0128
UNI-SET
1
Cleared 510(K)
K
82
0131
3M VOLUME VENTIATOR CIRCUIT
1
Cleared 510(K)
K
81
3384
DISPOSABLE NEONATAL VENTILATION CIRCUIT
1
Cleared 510(K)
K
81
3155
PEDIATRIC VENTILATOR CIRCUIT 2C7131
1
Cleared 510(K)
K
81
2773
BENNETT VOLUME VENTILATOR CIRCUIT
1
Cleared 510(K)
K
81
2774
VENTILATOR CIRCUIT
1
Cleared 510(K)
K
81
2737
RAIN-X
1
Cleared 510(K)
K
81
0341
LIFELINE IPPB SET-UP
1
Cleared 510(K)
K
80
1859
CAM-10 RESPIRATORY HOSE ASSEMBLIES
1
Cleared 510(K)
K
80
1087
NEONATAL BREATHING CIRCUIT SYSTEM
1
Cleared 510(K)
K
79
2268
CIRCAPAK
1
Cleared 510(K)
K
79
2047
CIRCUIT, BREATHING (W/ CONNECTOR, ADAPT,
1
Cleared 510(K)
K
79
2030
TWO-PIECE I.P.P.B. MANIFOLD-WITH RIGHT
1
Cleared 510(K)
K
79
1761
CIRCUIT, BREATHING W/WO NEBULIZER
1
Cleared 510(K)
K
79
1856
Y & ELBOW W/WO PORTS
1
Cleared 510(K)
K
79
1469
MANIFOLD/NEBULIZER BREATHING PRODUCTS
1
Cleared 510(K)
K
79
1060
RAIN-X
1
Cleared 510(K)
K
79
1034
PIGGYBACK BREATHING CIRCUIT
1
Cleared 510(K)
K
77
2069
VOL. VENTILATOR SETUP W/OUT NEBULIZER
1
Cleared 510(K)
K
77
0593
CORRUGATED TUBING #770 & 771
1
Cleared 510(K)
K
77
0581
CORRUGATED TUBING, 770 & 771
1
Cleared 510(K)
K
77
0354
TUBING, AEROSAL, DISPOSABLE
1
Cleared 510(K)
K
76
0993
MECK/MILLER VENTILATION TUBE HARNESS
1
Cleared 510(K)
BZR
Mixer, Breathing Gases, Anesthesia Inhalation
2
Product Code
CAD
Vaporizer, Anesthesia, Non-Heated
2
Product Code
CAE
Airway, Oropharyngeal, Anesthesiology
1
Product Code
CAF
Nebulizer (Direct Patient Interface)
2
Product Code
CAG
Circulator, Breathing-Circuit
2
Product Code
CAI
Circuit, Breathing (W Connector, Adaptor, Y Piece)
1
Product Code
CAL
Laryngoscope, Non-Rigid
1
Product Code
CAO
Airway, Esophageal (Obturator)
2
Product Code
CAT
Cannula, Nasal, Oxygen
1
Product Code
CAW
Generator, Oxygen, Portable
2
Product Code
CAZ
Anesthesia Conduction Kit
2
Product Code
CBF
Chamber, Hyperbaric
2
Product Code
CBG
Spreader, Cuff
1
Product Code
CBH
Device, Fixation, Tracheal Tube
1
Product Code
CBI
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
2
Product Code
CBK
Ventilator, Continuous, Facility Use
2
Product Code
CBL
Absorbent, Carbon-Dioxide
1
Product Code
CBN
Apparatus, Gas-Scavenging
2
Product Code
CBO
Attachment, Intermittent Mandatory Ventilation (Imv)
2
Product Code
CBP
Valve, Non-Rebreathing
2
Product Code
MOD
Accessory To Continuous Ventilator (Respirator)
2
Product Code
CCO
Bed, Rocking, Breathing Assist
2
Product Code
CCQ
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
1
Product Code
CCT
Applicator (Laryngo-Tracheal), Topical Anesthesia
2
Product Code
CCW
Laryngoscope, Rigid
1
Product Code
EPE
Brush, Cleaning, Tracheal Tube
1
Product Code
FNC
Tent, Pediatric Aerosol
2
Product Code
FOG
Hood, Oxygen, Infant
1
Product Code
JAY
Support, Breathing Tube
1
Product Code
JOH
Tube Tracheostomy And Tube Cuff
2
Product Code
KFZ
Humidifier, Non-Direct Patient Interface (Home-Use)
1
Product Code
KGB
Mask, Oxygen, Non-Rebreathing
1
Product Code
KHA
Mask, Scavenging
1
Product Code
LNZ
Changer, Tube, Endotracheal
2
Product Code
MIA
Needle, Spinal, Short Term
2
Product Code
MNS
Ventilator, Continuous, Non-Life-Supporting
2
Product Code
MNT
Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
2
Product Code
MRN
Apparatus, Nitric Oxide Delivery
2
Product Code
MRO
Apparatus, Nitric Oxide, Backup Delivery
2
Product Code
MZT
Device, Heimlich Maneuver Assist
2
Product Code
NFB
Conserver, Oxygen
2
Product Code
NHJ
Device, Positive Pressure Breathing, Intermittent
2
Product Code
NHK
Resuscitator, Manual, Non Self-Inflating
2
Product Code
NMA
Tube, Tracheal, Reprocessed
2
Product Code
NMC
Mask, Ventilator, Non-Continuous, Reprocessed
2
Product Code
NMR
Needle, Spinal, Short Term, Reprocessed
2
Product Code
NNH
Needle, Conduction, Anesthesia, Reprocessed
2
Product Code
NOU
Continuous, Ventilator, Home Use
2
Product Code
NQY
Ventilator, Continuous, Minimal Ventilatory Support, Home Use
2
Product Code
NVO
Spacer, Direct Patient Interface
2
Product Code
NVP
Holding Chambers, Direct Patient Interface
2
Product Code
NXA
Tracheotomy Care Kit
2
Product Code
OBN
Humidifier, Respiratory, Mask (Direct Patient Interface)
2
Product Code
OFQ
Anesthesia Kit
2
Product Code
OFT
Spinal Epidural Anesthesia Kit
2
Product Code
OFU
Spinal Anesthesia Kit
2
Product Code
OFV
Regional Anesthesia Kit
2
Product Code
OGA
Brachial Plexus Anesthesia Kit
2
Product Code
OGB
Caudal Anesthesia Kit
2
Product Code
OGC
Continuous Brachial Plexus Block Tray
2
Product Code
OGD
Custom Anesthesia Tray
2
Product Code
OGE
Epidural Anesthesia Kit
2
Product Code
OGF
Glossopharyngeal Anesthesia Kit
2
Product Code
OGG
Humidifier Nebulizer Kit
2
Product Code
OGH
Laryngoscope Kit
1
Product Code
OGI
Nasal Endotracheal Tube Holder Kit
1
Product Code
OGJ
Nerve Block Tray
2
Product Code
OGL
Oxygen Administration Kit
2
Product Code
OLF
Medevac Use Oxygen Generator
2
Product Code
ONZ
Mechanical Ventilator
2
Product Code
OQU
Airway Monitoring System
2
Product Code
PHS
Oral Airway Assist
1
Product Code
PMB
External Airway
2
Product Code
QAV
High Flow/High Velocity Humidified Oxygen Delivery Device
2
Product Code
QBY
Positive Airway Pressure System
2
Product Code
QCX
Retrograde Intubation Set
2
Product Code
OZR
Intraoral Pressure Gradient Device
2
Product Code
QFB
Isocapnic Ventilation Device
2
Product Code
Subpart G—Miscellaneous
CFR Sub-Part
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 6 December 2024 at 11:05 pm
AN
/
subpart-f—therapeutic-devices
/
BZO
/
K772069
View Source
VOL. VENTILATOR SETUP W/OUT NEBULIZER
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K772069
510(k) Type
Traditional
Applicant
INSPIRON CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/15/1977
Days to Decision
14 days
FDA Browser
by
Innolitics
Anesthesiology
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart C—Monitoring Devices
Subpart D—Prosthetic Devices
Subpart E—Surgical Devices
Subpart F—Cardiovascular Therapeutic Devices
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
BRW
Protector, Dental
BSF
Absorber, Carbon-Dioxide
BSJ
Mask, Gas, Anesthetic
BSK
Cuff, Tracheal Tube, Inflatable
BSN
Filter, Conduction, Anesthetic
BSO
Catheter, Conduction, Anesthetic
BSP
Needle, Conduction, Anesthetic (W/Wo Introducer)
BSR
Stylet, Tracheal Tube
BSZ
Gas-Machine, Anesthesia
BTB
Hook, Ether
BTC
Bag, Reservoir
BTK
Strap, Head, Gas Mask
BTL
Ventilator, Emergency, Powered (Resuscitator)
BTM
Ventilator, Emergency, Manual (Resuscitator)
BTO
Tube, Tracheostomy (W/Wo Connector)
BTP
Dropper, Ether
BTQ
Airway, Nasopharyngeal
BTR
Tube, Tracheal (W/Wo Connector)
BTS
Tube, Bronchial (W/Wo Connector)
BTT
Humidifier, Respiratory Gas, (Direct Patient Interface)
BWB
Forceps, Tube Introduction
BWC
Needle, Emergency Airway
BWF
Spirometer, Therapeutic (Incentive)
BWL
Apparatus, Electronanesthesia
BYD
Condenser, Heat And Moisture (Artificial Nose)
BYE
Attachment, Breathing, Positive End Expiratory Pressure
BYF
Mask, Oxygen, Low Concentration, Venturi
BYG
Mask, Oxygen
BYH
Drain, Tee (Water Trap)
BYI
Percussor, Powered-Electric
BYJ
Unit, Liquid-Oxygen, Portable
BYK
Tent, Oxygen, Electrically Powered
BYL
Tent, Oxygen
BYN
Chair, Posture, For Cardiac And Pulmonary Treatment
BYO
Bottle, Blow
BYP
Mouthpiece, Breathing
BYT
Ventilator, External Body, Negative Pressure, Adult (Cuirass)
BYW
Device, Rebreathing
BYX
Tubing, Pressure And Accessories
BZA
Connector, Airway (Extension)
BZB
Catheter, Nasal, Oxygen
BZD
Ventilator, Non-Continuous (Respirator)
BZE
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
BZO
Set, Tubing And Support, Ventilator (W Harness)
K
95
3784
UNICOR, INC. CORRUGATED TUBING
K
95
3785
UNICOR, INC. VENTILATOR HOSES
K
95
2011
PRIMA BREATHING BAGS
K
95
2010
PRIMA VENTILATOR HOSES
K
95
2012
PRIMA CUSTOM ANESTESIA CIRCUIT
K
95
2022
PRIMA VOLUMN VENTILATORSS
K
94
5740
INFANT FLOW SYSTEM
K
94
4531
PRIMA, INC. CORRUGATED TUBING
K
94
2572
VOLUME VENTILATOR
K
94
2569
VENTILATOR HOSE
K
93
5582
TUBE, INHALER OXYGEN
K
93
4753
STAR BREATHING CIRCUITS
K
93
2706
PRECISION MED PRODUCTS LTD. VENTILATOR HOSE
K
93
2712
PRECISION MED PRODUCTS LTD VOLUME VENTILATORS
K
93
2560
VOLUME VENTILATORS
K
93
2563
VENTILATOR HOSES
K
93
2119
CLEVELAND TUBING, INC. VENTILATOR HOSES
K
92
2479
DISPOSABLE ANESTHESIA BREATHING CIRCUIT, MODIFIED
K
92
1510
GAS SAMPLING KIT MODIFICATION
K
91
1328
UNIVERSAL VOLUME VENTILATOR CIRCUIT, MODIFICATION
K
90
3083
NEONATAL VENTILATOR CIRCUIT
K
90
3055
EXTENDED LIFE CIRCUITS
K
90
3404
FLOCARE F
K
89
6439
TUBING FLEXIBLE MEDICAL GAS LOW-PRESSURE
K
89
5853
SECHRIST DISPOSABLE INFANT BREATHING CIRCUIT
K
89
3760
CRITERION I.V. VENTILATOR BREATHING CIRCUIT #1004
K
89
0822
CIRCUIT BREATHING (W CONNECTOR, ADAPTER Y PIECE)
K
89
0011
OXYGEN CONNECTOR AND OXYGEN DELIVERY TUBING
K
88
4525
PEDIATRIC HUMIDIFIER TUBE W/ TEMPERATURE PORT
K
88
2341
QUICK CONNECT T ADAPTOR
K
88
0959
LIFEGUARD GAS SAMPLING LINE FOR MASS SPECTROMETRY
K
88
0637
BAXTER, PHARMASEAL PATIENT GAS SAMPLING LINES
K
87
4559
BABYFLEX PATIENT CIRCUIT
K
87
3900
PORTABLE VENTILATOR PATIENT CIRCUIT
K
87
3927
REUSEABLE BREATHING TUBES
K
86
3756
MODIFIED CRITERION VENTILATOR BREATHING CIRCUIT
K
86
3910
RAINCOAT
K
86
3033
PATIENT GAS SAMPLING KIT/5STAND ALONE VERSIONS
K
86
0659
END TIDAL CO2 SAMPLING CIRCUIT
K
86
1286
GAS SAMPLING KIT
K
86
0880
VENTILATOR CIRCUITS (VARIOUS TYPES)
K
86
0879
DISPOSABLE VENTILATOR CIRCUITS
K
85
0151
L100B UNIVERSAL & L100A NIGHT PATIENT CIRCUIT
K
85
0600
CO-AX VENTILATOR CIRCUIT
K
85
0703
SAF T FLO VENTILATOR TUBING
K
84
4290
L100D PATIENT CIRCUIT DUAL LINE
K
84
3036
PATIENT BREATHING CIRCUIT
K
84
2778
AVATRON UNIVERSAL ADULT VOL. VENTILATOR
K
84
2389
AVATRON DISPOSABLE I.P.P.B. CIRUCIT
K
84
1657
PATIENT TUBING HYTREL SIEMENS-ELEMA
K
84
1722
MASS SPECTROMETER INTERFACE
K
84
1637
THREE PORT SENSOR MANIFOLD
K
84
1378
VENT-WELL VENTILATOR TUBING
K
83
4569
VENTILATORY FREQUENCY MONITOR
K
83
4570
VOLUME VENTILATOR CIRCUIT W/WATER TRAP
K
83
3459
COAXIAL VOL. VENTILATOR CIRCUIT
K
83
2681
UNIVERSAL VOL. VENTILATOR 72 #1626
K
83
0923
TEMP-CHECK ADAPTOR, STRAIGHT CONFIGURA
K
83
0922
TEMP-CHECK ADAPTOR, TEE-CONFIGURATION
K
83
0921
TEMP-CHECK ADAPTOR, Y-CONFIGURATION
K
82
3481
BE #16 - MANIFOLD
K
82
3271
DISPOSABLE ADULT VO. VENTILATOR CIRCUIT
K
82
3479
MODUFLEX NEONATAL VENTILATOR SET
K
82
3287
RESPIRATORY CIRCUIT ADAPTOR
K
82
1064
INSPIRON NEONATAL VENTILATOR CIRCUIT
K
82
0128
UNI-SET
K
82
0131
3M VOLUME VENTIATOR CIRCUIT
K
81
3384
DISPOSABLE NEONATAL VENTILATION CIRCUIT
K
81
3155
PEDIATRIC VENTILATOR CIRCUIT 2C7131
K
81
2773
BENNETT VOLUME VENTILATOR CIRCUIT
K
81
2774
VENTILATOR CIRCUIT
K
81
2737
RAIN-X
K
81
0341
LIFELINE IPPB SET-UP
K
80
1859
CAM-10 RESPIRATORY HOSE ASSEMBLIES
K
80
1087
NEONATAL BREATHING CIRCUIT SYSTEM
K
79
2268
CIRCAPAK
K
79
2047
CIRCUIT, BREATHING (W/ CONNECTOR, ADAPT,
K
79
2030
TWO-PIECE I.P.P.B. MANIFOLD-WITH RIGHT
K
79
1761
CIRCUIT, BREATHING W/WO NEBULIZER
K
79
1856
Y & ELBOW W/WO PORTS
K
79
1469
MANIFOLD/NEBULIZER BREATHING PRODUCTS
K
79
1060
RAIN-X
K
79
1034
PIGGYBACK BREATHING CIRCUIT
K
77
2069
VOL. VENTILATOR SETUP W/OUT NEBULIZER
K
77
0593
CORRUGATED TUBING #770 & 771
K
77
0581
CORRUGATED TUBING, 770 & 771
K
77
0354
TUBING, AEROSAL, DISPOSABLE
K
76
0993
MECK/MILLER VENTILATION TUBE HARNESS
BZR
Mixer, Breathing Gases, Anesthesia Inhalation
CAD
Vaporizer, Anesthesia, Non-Heated
CAE
Airway, Oropharyngeal, Anesthesiology
CAF
Nebulizer (Direct Patient Interface)
CAG
Circulator, Breathing-Circuit
CAI
Circuit, Breathing (W Connector, Adaptor, Y Piece)
CAL
Laryngoscope, Non-Rigid
CAO
Airway, Esophageal (Obturator)
CAT
Cannula, Nasal, Oxygen
CAW
Generator, Oxygen, Portable
CAZ
Anesthesia Conduction Kit
CBF
Chamber, Hyperbaric
CBG
Spreader, Cuff
CBH
Device, Fixation, Tracheal Tube
CBI
Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
CBK
Ventilator, Continuous, Facility Use
CBL
Absorbent, Carbon-Dioxide
CBN
Apparatus, Gas-Scavenging
CBO
Attachment, Intermittent Mandatory Ventilation (Imv)
CBP
Valve, Non-Rebreathing
MOD
Accessory To Continuous Ventilator (Respirator)
CCO
Bed, Rocking, Breathing Assist
CCQ
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
CCT
Applicator (Laryngo-Tracheal), Topical Anesthesia
CCW
Laryngoscope, Rigid
EPE
Brush, Cleaning, Tracheal Tube
FNC
Tent, Pediatric Aerosol
FOG
Hood, Oxygen, Infant
JAY
Support, Breathing Tube
JOH
Tube Tracheostomy And Tube Cuff
KFZ
Humidifier, Non-Direct Patient Interface (Home-Use)
KGB
Mask, Oxygen, Non-Rebreathing
KHA
Mask, Scavenging
LNZ
Changer, Tube, Endotracheal
MIA
Needle, Spinal, Short Term
MNS
Ventilator, Continuous, Non-Life-Supporting
MNT
Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
MRN
Apparatus, Nitric Oxide Delivery
MRO
Apparatus, Nitric Oxide, Backup Delivery
MZT
Device, Heimlich Maneuver Assist
NFB
Conserver, Oxygen
NHJ
Device, Positive Pressure Breathing, Intermittent
NHK
Resuscitator, Manual, Non Self-Inflating
NMA
Tube, Tracheal, Reprocessed
NMC
Mask, Ventilator, Non-Continuous, Reprocessed
NMR
Needle, Spinal, Short Term, Reprocessed
NNH
Needle, Conduction, Anesthesia, Reprocessed
NOU
Continuous, Ventilator, Home Use
NQY
Ventilator, Continuous, Minimal Ventilatory Support, Home Use
NVO
Spacer, Direct Patient Interface
NVP
Holding Chambers, Direct Patient Interface
NXA
Tracheotomy Care Kit
OBN
Humidifier, Respiratory, Mask (Direct Patient Interface)
OFQ
Anesthesia Kit
OFT
Spinal Epidural Anesthesia Kit
OFU
Spinal Anesthesia Kit
OFV
Regional Anesthesia Kit
OGA
Brachial Plexus Anesthesia Kit
OGB
Caudal Anesthesia Kit
OGC
Continuous Brachial Plexus Block Tray
OGD
Custom Anesthesia Tray
OGE
Epidural Anesthesia Kit
OGF
Glossopharyngeal Anesthesia Kit
OGG
Humidifier Nebulizer Kit
OGH
Laryngoscope Kit
OGI
Nasal Endotracheal Tube Holder Kit
OGJ
Nerve Block Tray
OGL
Oxygen Administration Kit
OLF
Medevac Use Oxygen Generator
ONZ
Mechanical Ventilator
OQU
Airway Monitoring System
PHS
Oral Airway Assist
PMB
External Airway
QAV
High Flow/High Velocity Humidified Oxygen Delivery Device
QBY
Positive Airway Pressure System
QCX
Retrograde Intubation Set
OZR
Intraoral Pressure Gradient Device
QFB
Isocapnic Ventilation Device
Subpart G—Miscellaneous
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
AN
/
subpart-f—therapeutic-devices
/
BZO
/
K772069
View Source
VOL. VENTILATOR SETUP W/OUT NEBULIZER
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K772069
510(k) Type
Traditional
Applicant
INSPIRON CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/15/1977
Days to Decision
14 days