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
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
K
22
0290
Revitalair 430+
2
Cleared 510(K)
K
17
1899
Revitalair 430F
2
Cleared 510(K)
K
16
3109
OxyHeal 4000 Multiplace Hyperbaric Chamber Family
2
Cleared 510(K)
K
15
2223
Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System
2
Cleared 510(K)
K
14
0559
SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER
2
Cleared 510(K)
K
10
2831
RSI 4200
2
Cleared 510(K)
K
09
2991
O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING)
2
Cleared 510(K)
K
10
1262
FLEXI-LITE
2
Cleared 510(K)
K
10
0268
SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER
2
Cleared 510(K)
K
08
2455
RECTANGULAR MULTIPLACE HYPERBARIC CHAMBER
2
Cleared 510(K)
K
08
1506
HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS
2
Cleared 510(K)
K
07
2427
SIGMA SERIES HYPERBARIC CHAMBER
2
Cleared 510(K)
K
07
2757
DIVE AND SHALLOW AND GRAND DIVE
2
Cleared 510(K)
K
06
0739
MONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM, MODEL BLKS-307
2
Cleared 510(K)
K
05
3498
HYPEROX 101
2
Cleared 510(K)
K
05
2866
OXYHEAL 1000 MONOPLACE HYPERBARIC CHAMBER
2
Cleared 510(K)
K
05
1759
FLEXI-LITE, MODEL FL-V1.2
2
Cleared 510(K)
K
05
2713
MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER
2
Cleared 510(K)
K
04
0145
ATA HCM MONOPLACE HYPERBARIC SYSTEM
2
Cleared 510(K)
K
04
1007
MILLENIUM, MODELS 2000, 2001 AND 2002
2
Cleared 510(K)
K
03
0418
MULTIPLACE HYPERBARIC SYSTEM, MODEL MMI HYPERBARIC CHAMBER SYSTEM
2
Cleared 510(K)
K
03
0713
BAY AREA HYPERSCIENCES
2
Cleared 510(K)
K
03
1649
SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES
2
Cleared 510(K)
K
02
2214
MSI I2010 DUAL PLACE HYPERBARIC CHAMBER
2
Cleared 510(K)
K
02
1689
PAN-AMERICA HYPERBARICS, HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M10+2
2
Cleared 510(K)
K
02
1693
PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-S1
2
Cleared 510(K)
K
02
1690
PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M3+1
2
Cleared 510(K)
K
02
0974
BARA-MED ACRYLIC MONOPLACE HYPERBARIC CHAMBER
2
Cleared 510(K)
K
01
1592
OXYGEN TREATMENT HOOD
2
Cleared 510(K)
K
01
1866
OXYHEAL 2000 HYPERBARIC CHAMBER SERIES, MODEL OXYHEAL 2000 SERIES
2
Cleared 510(K)
K
00
1121
OXYGEN APPLIED SYMPTOM IMPROVEMENT SYSTEM (OASIS)
2
Cleared 510(K)
K
01
1565
INFANT OXYGEN TREATMENT HOOD
2
Cleared 510(K)
K
01
1312
BLKS-303 MK MONOPLACE HYPERBARIC SYSTEM
2
Cleared 510(K)
K
01
0659
SEA-LONG MEDICAL TREATMENT HOOD
2
Cleared 510(K)
K
00
2794
MODEL 5000 MULTIPLACE HYPERBARIC THERAPY
2
Cleared 510(K)
K
00
2795
MODEL HYBRID 3200 MONOPLACE, HYPERBARIC THERAPY SYSTEMS
2
Cleared 510(K)
K
00
1409
GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER
2
Cleared 510(K)
K
99
3010
BARA-MED, ACRYLIC MONOPLACE HYPERBARIC CHAMBER
2
Cleared 510(K)
K
99
0927
SIGMA 3400 MONOPLACE HYPERBARIC CHAMBER
2
Cleared 510(K)
K
98
4313
HTU3
2
Cleared 510(K)
K
98
1938
TAMPA HYPERBARIC MONOPLACE CHAMBER
2
Cleared 510(K)
K
98
3648
SIGMA PLUS/ II MULTIPLACE HYPERBARIC SYSTEM
2
Cleared 510(K)
K
97
2908
SANDS SERIES III HYPERBARIC CHAMBER
2
Cleared 510(K)
K
97
4868
SIGMA PLUS MONOPLACE HYPERBARIC CHAMBER
2
Cleared 510(K)
K
95
2545
WRIGHT 1000 MONOPLACE HYPERBARIC SYSTEM
2
Cleared 510(K)
K
96
0389
HYPERBARIC CHAMBER
2
Cleared 510(K)
K
96
2869
GSP1 - GAS SELECTION PANEL
2
Cleared 510(K)
K
96
2871
ODS1 - HOOD DRIVER
2
Cleared 510(K)
K
95
5535
LOUISVILLE LABS OXYGEN HEAD TENT
2
Cleared 510(K)
K
95
1044
SYSTEM ONE HYPERBARIC CHAMBER
2
Cleared 510(K)
K
95
4387
T CLASS HYPERBARIC FACILITIES
2
Cleared 510(K)
K
95
0386
MODEL 3200P/3200PR HYPERBARIC CHAMBER
2
Cleared 510(K)
K
93
4164
MODEL 2500E/2500ER HYPERBARIC CHAMBER
2
Cleared 510(K)
K
95
1125
LIFEFORCE CLINICAL HYPERBARIC FACILITY
2
Cleared 510(K)
K
95
0957
MULTIPLACE HYPERBARIC TREATMENT CHAMBER SYSTEM
2
Cleared 510(K)
K
93
3929
LAB-SITE(R) SAFETY CANNULA
2
Cleared 510(K)
K
93
0748
SIGMA MP MULTIPLACE HYPERBARIC CHAMBER
2
Cleared 510(K)
K
90
5168
HYPERLITE
2
Cleared 510(K)
K
87
4752
GAMOW HYPERBARIC BAG
2
Cleared 510(K)
K
87
4107
H.T.U. (HYPERBARIC THERAPY UNIT)
2
Cleared 510(K)
K
86
2198
SIGMA II - DUAL PLACE HYPERBARIC CHAMBER
2
Cleared 510(K)
K
86
1315
HYPERBARIC PENETRATION EXTENSION SET
2
Cleared 510(K)
K
85
0563
SECHRIST VENTILATOR/NAUTILUS CHAMBER COMBINATION
2
Cleared 510(K)
K
84
2303
MICROSPAN -PH MONITOR
2
Cleared 510(K)
K
84
0841
RENEAU UNIT
2
Cleared 510(K)
K
84
1608
MODEL 3000 HYPERBARIC CHAMBER
2
Cleared 510(K)
K
83
2127
NAUTILUS MONOPLACE HYPERBARIC UNIT
2
Cleared 510(K)
K
79
0693
HYPERBARIC OXYGEN CHAMBER
2
Cleared 510(K)
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
/
CBF
/
K001121
View Source
OXYGEN APPLIED SYMPTOM IMPROVEMENT SYSTEM (OASIS)
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K001121
510(k) Type
Abbreviated
Applicant
ENGINEERED MEDICAL TECHNOLOGY, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/29/2001
Days to Decision
601 days
Submission Type
Summary
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)
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
K
22
0290
Revitalair 430+
K
17
1899
Revitalair 430F
K
16
3109
OxyHeal 4000 Multiplace Hyperbaric Chamber Family
K
15
2223
Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System
K
14
0559
SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER
K
10
2831
RSI 4200
K
09
2991
O.S.C.A.R. (OPERATING SYSTEM FOR CONTROL AND RECORD KEEPING)
K
10
1262
FLEXI-LITE
K
10
0268
SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER
K
08
2455
RECTANGULAR MULTIPLACE HYPERBARIC CHAMBER
K
08
1506
HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS
K
07
2427
SIGMA SERIES HYPERBARIC CHAMBER
K
07
2757
DIVE AND SHALLOW AND GRAND DIVE
K
06
0739
MONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM, MODEL BLKS-307
K
05
3498
HYPEROX 101
K
05
2866
OXYHEAL 1000 MONOPLACE HYPERBARIC CHAMBER
K
05
1759
FLEXI-LITE, MODEL FL-V1.2
K
05
2713
MODEL 3300E/ER MONOPLACE HYPERBARIC OXYGEN CHAMBER
K
04
0145
ATA HCM MONOPLACE HYPERBARIC SYSTEM
K
04
1007
MILLENIUM, MODELS 2000, 2001 AND 2002
K
03
0418
MULTIPLACE HYPERBARIC SYSTEM, MODEL MMI HYPERBARIC CHAMBER SYSTEM
K
03
0713
BAY AREA HYPERSCIENCES
K
03
1649
SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES
K
02
2214
MSI I2010 DUAL PLACE HYPERBARIC CHAMBER
K
02
1689
PAN-AMERICA HYPERBARICS, HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M10+2
K
02
1693
PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-S1
K
02
1690
PAN-AMERICA HYPERBARICS HYPERBARIC CHAMBER SYSTEM, MODEL PAH-M3+1
K
02
0974
BARA-MED ACRYLIC MONOPLACE HYPERBARIC CHAMBER
K
01
1592
OXYGEN TREATMENT HOOD
K
01
1866
OXYHEAL 2000 HYPERBARIC CHAMBER SERIES, MODEL OXYHEAL 2000 SERIES
K
00
1121
OXYGEN APPLIED SYMPTOM IMPROVEMENT SYSTEM (OASIS)
K
01
1565
INFANT OXYGEN TREATMENT HOOD
K
01
1312
BLKS-303 MK MONOPLACE HYPERBARIC SYSTEM
K
01
0659
SEA-LONG MEDICAL TREATMENT HOOD
K
00
2794
MODEL 5000 MULTIPLACE HYPERBARIC THERAPY
K
00
2795
MODEL HYBRID 3200 MONOPLACE, HYPERBARIC THERAPY SYSTEMS
K
00
1409
GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER
K
99
3010
BARA-MED, ACRYLIC MONOPLACE HYPERBARIC CHAMBER
K
99
0927
SIGMA 3400 MONOPLACE HYPERBARIC CHAMBER
K
98
4313
HTU3
K
98
1938
TAMPA HYPERBARIC MONOPLACE CHAMBER
K
98
3648
SIGMA PLUS/ II MULTIPLACE HYPERBARIC SYSTEM
K
97
2908
SANDS SERIES III HYPERBARIC CHAMBER
K
97
4868
SIGMA PLUS MONOPLACE HYPERBARIC CHAMBER
K
95
2545
WRIGHT 1000 MONOPLACE HYPERBARIC SYSTEM
K
96
0389
HYPERBARIC CHAMBER
K
96
2869
GSP1 - GAS SELECTION PANEL
K
96
2871
ODS1 - HOOD DRIVER
K
95
5535
LOUISVILLE LABS OXYGEN HEAD TENT
K
95
1044
SYSTEM ONE HYPERBARIC CHAMBER
K
95
4387
T CLASS HYPERBARIC FACILITIES
K
95
0386
MODEL 3200P/3200PR HYPERBARIC CHAMBER
K
93
4164
MODEL 2500E/2500ER HYPERBARIC CHAMBER
K
95
1125
LIFEFORCE CLINICAL HYPERBARIC FACILITY
K
95
0957
MULTIPLACE HYPERBARIC TREATMENT CHAMBER SYSTEM
K
93
3929
LAB-SITE(R) SAFETY CANNULA
K
93
0748
SIGMA MP MULTIPLACE HYPERBARIC CHAMBER
K
90
5168
HYPERLITE
K
87
4752
GAMOW HYPERBARIC BAG
K
87
4107
H.T.U. (HYPERBARIC THERAPY UNIT)
K
86
2198
SIGMA II - DUAL PLACE HYPERBARIC CHAMBER
K
86
1315
HYPERBARIC PENETRATION EXTENSION SET
K
85
0563
SECHRIST VENTILATOR/NAUTILUS CHAMBER COMBINATION
K
84
2303
MICROSPAN -PH MONITOR
K
84
0841
RENEAU UNIT
K
84
1608
MODEL 3000 HYPERBARIC CHAMBER
K
83
2127
NAUTILUS MONOPLACE HYPERBARIC UNIT
K
79
0693
HYPERBARIC OXYGEN CHAMBER
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
/
CBF
/
K001121
View Source
OXYGEN APPLIED SYMPTOM IMPROVEMENT SYSTEM (OASIS)
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K001121
510(k) Type
Abbreviated
Applicant
ENGINEERED MEDICAL TECHNOLOGY, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
11/29/2001
Days to Decision
601 days
Submission Type
Summary