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
K
01
1134
OXYGEN SUPPLY TUBING, MODEL 1115
1
Cleared 510(K)
K
95
5656
NORTH STATE PLASTICS AEROSOL TEE
1
Cleared 510(K)
K
94
3110
GAS SAMPLING INTERFACES
1
Cleared 510(K)
K
93
5835
BUSSE PLASTIC TUBING CONNECTORS AND ACCESSORIES
1
Cleared 510(K)
K
93
1043
MF OHMEDA STYLE MEDICAL GAS WALL OUTLETS
1
Cleared 510(K)
K
93
1033
MF CHEMETRON STYLE MEDICAL GAS WALL OUTLETS
1
Cleared 510(K)
K
91
3422
OXYGEN TUBING, 81503
1
Cleared 510(K)
K
91
4980
HEX, QUAD, OR RAIL BLOCK MANIFOLD ACCESSORIES
1
Cleared 510(K)
K
91
2763
OHMEDA STYLE CHECK UNITS (FEMALE COUPLERS)
1
Cleared 510(K)
K
90
5091
VARIOUS MALE QUICK CONNECTS.
1
Cleared 510(K)
K
90
5094
SCHRADER OXYGEN/AIR VAC&NITR-OXIDE MALE QUICK CONN
1
Cleared 510(K)
K
90
4757
OXYGEN, AIR, VACUUM & NITROUS-OXIDE COUPLERS
1
Cleared 510(K)
K
90
4702
MEDI FITT/OXEQUIP OXYGEN/AIR MALE QUICK CONNECTS
1
Cleared 510(K)
K
90
4701
MEDI FITT/OHMEDA OXY/AIR/VAC&NIT-OXI MALE QK CONN
1
Cleared 510(K)
K
90
4337
OXYGEN, AIR, VACUUM AND NITROUS-OXIDE MALE CONN.
1
Cleared 510(K)
K
90
1983
OXYGEN, AIR & VACUUM COUPLER & NITROUS-OXIDE COUP.
1
Cleared 510(K)
K
90
1961
OXYGEN COUPLER, AIR COUPLER & VACUUM COUPLER
1
Cleared 510(K)
K
86
3912
THE MMG 5 IN 1 CONNECTOR
1
Cleared 510(K)
K
86
0877
FLEXTUBE, CONNECTING TUBING
1
Cleared 510(K)
K
85
4239
OXYCOIL
1
Cleared 510(K)
K
85
3569
MEDIPART CORRUGATED POLYETHYLENE & E.V.A. TUBING
1
Cleared 510(K)
K
85
2081
PENNINE OXYGEN LINK TUBING
1
Cleared 510(K)
K
84
1901
OXYMIZER FLOW RESTRICTOR
1
Cleared 510(K)
K
84
0790
UNIVERSAL OXYGEN TUBING CONNECTOR
1
Cleared 510(K)
K
83
2660
OXYGEN CONNECTING TUBESET-RESPIRATORY
1
Cleared 510(K)
K
83
1146
OXYCOIL
1
Cleared 510(K)
K
83
1082
CONNECTING TUBING
1
Cleared 510(K)
K
83
0988
OXYGEN CONNECTING TUBE
1
Cleared 510(K)
K
82
3246
AUSTIN INHALATOR
1
Cleared 510(K)
K
82
3142
OXYGEN TUBINGS
1
Cleared 510(K)
K
81
3074
CONNECTORS & ADAPTERS
1
Cleared 510(K)
K
81
3197
OXYGEN CONNECTING TUBE
1
Cleared 510(K)
K
81
3234
OHIO AIR ADAPTOR
1
Cleared 510(K)
K
81
1551
TIMETER PRODUCED OHIO OXYGEN ADAPTOR
1
Cleared 510(K)
K
81
1550
TIMETER PRODUCED CHEMETRON (NCG) AIR
1
Cleared 510(K)
K
81
1549
TIMETER PRODUCED SCHRADER OXYGEN ADAPTOR
1
Cleared 510(K)
K
81
0652
TUBING CONNECTORS
1
Cleared 510(K)
K
81
0362
CORRUGATED FLEX TUBING
1
Cleared 510(K)
K
81
0344
OXYGEN TUBING
1
Cleared 510(K)
K
81
0374
CORRUGATED FLEX TUBING #6000,
1
Cleared 510(K)
K
80
2071
OXYGEN SUPPLY TUBING
1
Cleared 510(K)
K
80
1514
TIMETER PRODUCED PURRITAN BENNETT O2 ADP
1
Cleared 510(K)
K
80
1261
DISPOSABLE COUPLING ADAPTOR
1
Cleared 510(K)
K
80
1260
DISPOSABLE PRESSURE LINE ADAPTOR
1
Cleared 510(K)
K
80
1190
OXYGEN TUBING (CRUSH RESISTANT)/VINYL TP
1
Cleared 510(K)
K
80
0664
SURE FLOW TUBING
1
Cleared 510(K)
K
80
0509
CONNECTING TUBES
1
Cleared 510(K)
K
80
0504
OXYGEN CONNECTING TUBES
1
Cleared 510(K)
K
79
1851
RED CAP, M-502
1
Cleared 510(K)
K
79
1848
RESPIROMETER MANIFOLD M-505
1
Cleared 510(K)
K
79
1821
CORRUGATED FLEXIBLE POLYETHYLENE & EVA
1
Cleared 510(K)
K
79
0928
3-WAY T 22MM MALE
1
Cleared 510(K)
K
79
0158
TUBING, E.V.A. FLEXIBLE
1
Cleared 510(K)
K
79
0159
CORRUGATED FLEXIBLE E.V.A. TUBING
1
Cleared 510(K)
K
79
0160
OXYGEN TUBING, W/VINYL AND LATEX TIPS
1
Cleared 510(K)
K
79
0147
TUBING CORRUGATED
1
Cleared 510(K)
K
79
0150
BIRD DRIVE LINE ADAPTOR
1
Cleared 510(K)
K
78
1428
FLEXTUBES:9, 20, 26
1
Cleared 510(K)
K
78
1416
TUBING, FLEXIBLE, MEDICAL GAS
1
Cleared 510(K)
K
78
1231
OXYGEN SUPPLY TUBE, DISP., PLASTIC
1
Cleared 510(K)
K
77
1075
OXYGEN CONNECTING TUBE #017205
1
Cleared 510(K)
K
76
0220
TUBING, SINGLE USE OXYGEN SUPPLY
1
Cleared 510(K)
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
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 16 August 2024 at 11:05 pm
AN
/
subpart-f—therapeutic-devices
/
BYX
/
K901983
View Source
OXYGEN, AIR & VACUUM COUPLER & NITROUS-OXIDE COUP.
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K901983
510(k) Type
Traditional
Applicant
MEDICAL FITTINGS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/14/1990
Days to Decision
104 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
K
01
1134
OXYGEN SUPPLY TUBING, MODEL 1115
K
95
5656
NORTH STATE PLASTICS AEROSOL TEE
K
94
3110
GAS SAMPLING INTERFACES
K
93
5835
BUSSE PLASTIC TUBING CONNECTORS AND ACCESSORIES
K
93
1043
MF OHMEDA STYLE MEDICAL GAS WALL OUTLETS
K
93
1033
MF CHEMETRON STYLE MEDICAL GAS WALL OUTLETS
K
91
3422
OXYGEN TUBING, 81503
K
91
4980
HEX, QUAD, OR RAIL BLOCK MANIFOLD ACCESSORIES
K
91
2763
OHMEDA STYLE CHECK UNITS (FEMALE COUPLERS)
K
90
5091
VARIOUS MALE QUICK CONNECTS.
K
90
5094
SCHRADER OXYGEN/AIR VAC&NITR-OXIDE MALE QUICK CONN
K
90
4757
OXYGEN, AIR, VACUUM & NITROUS-OXIDE COUPLERS
K
90
4702
MEDI FITT/OXEQUIP OXYGEN/AIR MALE QUICK CONNECTS
K
90
4701
MEDI FITT/OHMEDA OXY/AIR/VAC&NIT-OXI MALE QK CONN
K
90
4337
OXYGEN, AIR, VACUUM AND NITROUS-OXIDE MALE CONN.
K
90
1983
OXYGEN, AIR & VACUUM COUPLER & NITROUS-OXIDE COUP.
K
90
1961
OXYGEN COUPLER, AIR COUPLER & VACUUM COUPLER
K
86
3912
THE MMG 5 IN 1 CONNECTOR
K
86
0877
FLEXTUBE, CONNECTING TUBING
K
85
4239
OXYCOIL
K
85
3569
MEDIPART CORRUGATED POLYETHYLENE & E.V.A. TUBING
K
85
2081
PENNINE OXYGEN LINK TUBING
K
84
1901
OXYMIZER FLOW RESTRICTOR
K
84
0790
UNIVERSAL OXYGEN TUBING CONNECTOR
K
83
2660
OXYGEN CONNECTING TUBESET-RESPIRATORY
K
83
1146
OXYCOIL
K
83
1082
CONNECTING TUBING
K
83
0988
OXYGEN CONNECTING TUBE
K
82
3246
AUSTIN INHALATOR
K
82
3142
OXYGEN TUBINGS
K
81
3074
CONNECTORS & ADAPTERS
K
81
3197
OXYGEN CONNECTING TUBE
K
81
3234
OHIO AIR ADAPTOR
K
81
1551
TIMETER PRODUCED OHIO OXYGEN ADAPTOR
K
81
1550
TIMETER PRODUCED CHEMETRON (NCG) AIR
K
81
1549
TIMETER PRODUCED SCHRADER OXYGEN ADAPTOR
K
81
0652
TUBING CONNECTORS
K
81
0362
CORRUGATED FLEX TUBING
K
81
0344
OXYGEN TUBING
K
81
0374
CORRUGATED FLEX TUBING #6000,
K
80
2071
OXYGEN SUPPLY TUBING
K
80
1514
TIMETER PRODUCED PURRITAN BENNETT O2 ADP
K
80
1261
DISPOSABLE COUPLING ADAPTOR
K
80
1260
DISPOSABLE PRESSURE LINE ADAPTOR
K
80
1190
OXYGEN TUBING (CRUSH RESISTANT)/VINYL TP
K
80
0664
SURE FLOW TUBING
K
80
0509
CONNECTING TUBES
K
80
0504
OXYGEN CONNECTING TUBES
K
79
1851
RED CAP, M-502
K
79
1848
RESPIROMETER MANIFOLD M-505
K
79
1821
CORRUGATED FLEXIBLE POLYETHYLENE & EVA
K
79
0928
3-WAY T 22MM MALE
K
79
0158
TUBING, E.V.A. FLEXIBLE
K
79
0159
CORRUGATED FLEXIBLE E.V.A. TUBING
K
79
0160
OXYGEN TUBING, W/VINYL AND LATEX TIPS
K
79
0147
TUBING CORRUGATED
K
79
0150
BIRD DRIVE LINE ADAPTOR
K
78
1428
FLEXTUBES:9, 20, 26
K
78
1416
TUBING, FLEXIBLE, MEDICAL GAS
K
78
1231
OXYGEN SUPPLY TUBE, DISP., PLASTIC
K
77
1075
OXYGEN CONNECTING TUBE #017205
K
76
0220
TUBING, SINGLE USE OXYGEN SUPPLY
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)
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
/
BYX
/
K901983
View Source
OXYGEN, AIR & VACUUM COUPLER & NITROUS-OXIDE COUP.
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K901983
510(k) Type
Traditional
Applicant
MEDICAL FITTINGS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/14/1990
Days to Decision
104 days