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
K
96
3298
FIRST AID KIT(S)
1
Cleared 510(K)
K
96
2848
HANS RUDOLPH NASAL CPAP MASK
1
Cleared 510(K)
K
94
5482
DISPOSABLE, CPAP OXYGEN MASK
1
Cleared 510(K)
K
95
3464
WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK
1
Cleared 510(K)
K
95
3039
VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS
1
Cleared 510(K)
K
94
5472
WESTMED PEDIATRIC AND ADULT AEROSOL MASK
1
Cleared 510(K)
K
94
2907
JEMSDAL MASK
1
Cleared 510(K)
K
94
0887
SYSTEM 22 ADULT MASK
1
Cleared 510(K)
K
94
0888
SYSTEM 22 PAEDIATRIC MASK
1
Cleared 510(K)
K
93
1952
MEDWAY OXYGEN MASK
1
Cleared 510(K)
K
92
4069
SURGICO OXYGEN MASK
1
Cleared 510(K)
K
92
1499
SEAL RING FOR NASAL CPAP
1
Cleared 510(K)
K
91
3501
TRACHEOSTOMY MASK
1
Cleared 510(K)
K
91
3383
OXYGEN MASKS 81420, 81421, 81471 & 81461
1
Cleared 510(K)
K
91
3275
VENTURI OXYGEN MASK
1
Cleared 510(K)
K
91
3455
OXYGEN MASKS 82400 & 82405
1
Cleared 510(K)
K
91
2633
SALTER LABS INFANT MEDIUM CONCENTRATION MASK
1
Cleared 510(K)
K
90
5288
ANESTHESIA/RESPIRATORY FACE MASK, VARIOUS SIZES
1
Cleared 510(K)
K
90
4719
DISPOSABLE FACE MASK
1
Cleared 510(K)
K
90
4195
DISPOSABLE FACE MASK
1
Cleared 510(K)
K
89
6773
DISPOSABLE FACE MASK
1
Cleared 510(K)
K
89
4642
SLEEPAP MASK
1
Cleared 510(K)
K
89
2434
KENDALL CURITY OXYGEN MASK
1
Cleared 510(K)
K
89
0193
SINGLE PATIENT USE NASAL (CPAP) CIRCUIT
1
Cleared 510(K)
K
87
4092
MASK, OXYGEN
1
Cleared 510(K)
K
87
0206
CRYSTAL MASK
1
Cleared 510(K)
K
86
5047
SALTER LABS #4004/4104 OXYGEN MASK W/C02 SAMP LINE
1
Cleared 510(K)
K
86
0871
TRACHEOSTOMY MASKS/ADULT & PAEDIATRIC
1
Cleared 510(K)
K
86
0869
MEDIUM CONCENTRATION OXYGEN MASKS
1
Cleared 510(K)
K
86
0870
AEROSOL MASKS/ADULT & PAEDIATRIC
1
Cleared 510(K)
K
85
2629
AERO-MASK TWO
1
Cleared 510(K)
K
85
2623
OXY-ONE
1
Cleared 510(K)
K
85
2624
OXY-TWO
1
Cleared 510(K)
K
85
2626
AERO-MASK ONE
1
Cleared 510(K)
K
85
1466
CARNATION - OXYGEN MASK
1
Cleared 510(K)
K
85
0626
CARNATION OXYGEN
1
Cleared 510(K)
K
82
3532
STOCK #64091-PEDIATRIC OXYGEN MASK
1
Cleared 510(K)
K
82
3141
OXYGEN MASKS
1
Cleared 510(K)
K
81
2208
NASAL OXYGEN CANNULA OXYGEN MASK
1
Cleared 510(K)
K
81
1711
PEDIATRIC OXYGEN MASKS
1
Cleared 510(K)
K
81
0340
ADULT MASKS & PEDIATRIC MASKS
1
Cleared 510(K)
K
80
2323
PEDIATRIC OXYGEN OR AEROSOL MASKS,
1
Cleared 510(K)
K
80
1883
PEEP FACE MASK
1
Cleared 510(K)
K
79
0934
OXYGEN BARB M-552
1
Cleared 510(K)
K
79
0166
OXYGEN MASK, ADULT VINYL
1
Cleared 510(K)
K
79
0163
AEROSOL MASK
1
Cleared 510(K)
K
79
0165
OXYGEN MASK-HIGH CONCENTRATION
1
Cleared 510(K)
K
79
0164
OXYGEN MASK REBREATHER
1
Cleared 510(K)
K
78
1741
MASK, BI FLO NASAL OXYGEN
1
Cleared 510(K)
K
78
1055
FACE TENTS
1
Cleared 510(K)
K
77
2141
AEROSOL & OXYGEN MASKS
1
Cleared 510(K)
K
77
0995
AEROSOL MASK
1
Cleared 510(K)
K
76
0941
MASK ARTIFICIAL RESPIRATION
1
Cleared 510(K)
K
76
0329
MASK, DISPOSABLE OXYGEN THERAPY
1
Cleared 510(K)
K
76
0219
MASKA, OXYGEN VINYL D-SP. SINGLE USE
1
Cleared 510(K)
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
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
/
BYG
/
K812208
View Source
NASAL OXYGEN CANNULA OXYGEN MASK
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K812208
510(k) Type
Traditional
Applicant
KAMEI INTL. CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/25/1981
Days to Decision
21 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
K
96
3298
FIRST AID KIT(S)
K
96
2848
HANS RUDOLPH NASAL CPAP MASK
K
94
5482
DISPOSABLE, CPAP OXYGEN MASK
K
95
3464
WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK
K
95
3039
VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS
K
94
5472
WESTMED PEDIATRIC AND ADULT AEROSOL MASK
K
94
2907
JEMSDAL MASK
K
94
0887
SYSTEM 22 ADULT MASK
K
94
0888
SYSTEM 22 PAEDIATRIC MASK
K
93
1952
MEDWAY OXYGEN MASK
K
92
4069
SURGICO OXYGEN MASK
K
92
1499
SEAL RING FOR NASAL CPAP
K
91
3501
TRACHEOSTOMY MASK
K
91
3383
OXYGEN MASKS 81420, 81421, 81471 & 81461
K
91
3275
VENTURI OXYGEN MASK
K
91
3455
OXYGEN MASKS 82400 & 82405
K
91
2633
SALTER LABS INFANT MEDIUM CONCENTRATION MASK
K
90
5288
ANESTHESIA/RESPIRATORY FACE MASK, VARIOUS SIZES
K
90
4719
DISPOSABLE FACE MASK
K
90
4195
DISPOSABLE FACE MASK
K
89
6773
DISPOSABLE FACE MASK
K
89
4642
SLEEPAP MASK
K
89
2434
KENDALL CURITY OXYGEN MASK
K
89
0193
SINGLE PATIENT USE NASAL (CPAP) CIRCUIT
K
87
4092
MASK, OXYGEN
K
87
0206
CRYSTAL MASK
K
86
5047
SALTER LABS #4004/4104 OXYGEN MASK W/C02 SAMP LINE
K
86
0871
TRACHEOSTOMY MASKS/ADULT & PAEDIATRIC
K
86
0869
MEDIUM CONCENTRATION OXYGEN MASKS
K
86
0870
AEROSOL MASKS/ADULT & PAEDIATRIC
K
85
2629
AERO-MASK TWO
K
85
2623
OXY-ONE
K
85
2624
OXY-TWO
K
85
2626
AERO-MASK ONE
K
85
1466
CARNATION - OXYGEN MASK
K
85
0626
CARNATION OXYGEN
K
82
3532
STOCK #64091-PEDIATRIC OXYGEN MASK
K
82
3141
OXYGEN MASKS
K
81
2208
NASAL OXYGEN CANNULA OXYGEN MASK
K
81
1711
PEDIATRIC OXYGEN MASKS
K
81
0340
ADULT MASKS & PEDIATRIC MASKS
K
80
2323
PEDIATRIC OXYGEN OR AEROSOL MASKS,
K
80
1883
PEEP FACE MASK
K
79
0934
OXYGEN BARB M-552
K
79
0166
OXYGEN MASK, ADULT VINYL
K
79
0163
AEROSOL MASK
K
79
0165
OXYGEN MASK-HIGH CONCENTRATION
K
79
0164
OXYGEN MASK REBREATHER
K
78
1741
MASK, BI FLO NASAL OXYGEN
K
78
1055
FACE TENTS
K
77
2141
AEROSOL & OXYGEN MASKS
K
77
0995
AEROSOL MASK
K
76
0941
MASK ARTIFICIAL RESPIRATION
K
76
0329
MASK, DISPOSABLE OXYGEN THERAPY
K
76
0219
MASKA, OXYGEN VINYL D-SP. SINGLE USE
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)
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
/
BYG
/
K812208
View Source
NASAL OXYGEN CANNULA OXYGEN MASK
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K812208
510(k) Type
Traditional
Applicant
KAMEI INTL. CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/25/1981
Days to Decision
21 days