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
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
K
22
0591
Proxima
2
Cleared 510(K)
K
22
1014
Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile
2
Cleared 510(K)
K
20
0401
Apogee
2
Cleared 510(K)
K
15
1506
Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula
2
Cleared 510(K)
K
13
1023
THERAFLOW SINGLE LUMEN AND THERAFLOW DUAL LUMEN
2
Cleared 510(K)
K
11
3111
CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER WITH MOTION
2
Cleared 510(K)
K
10
3392
CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER
2
Cleared 510(K)
K
09
0421
MODEL 350G GAS CONSERVER
2
Cleared 510(K)
K
07
0740
CHAD THERAPEUTICS BONSAI MODEL 800
2
Cleared 510(K)
K
06
0751
INOVO, INC. ACCUPULSE SINGLE LUMEN CONSERVING REGULATOR
2
Cleared 510(K)
K
06
0382
FLO-RITE, MODEL 478-1; FLO-RITE II, MODEL 478-1; SIMPULSE II, MODEL 478-2S; NUMATIX, MODEL NCD401; SIMPULSE, MODEL 478-1
2
Cleared 510(K)
K
05
2563
INOGEN SATELLITE CONSERVER, MODEL SC-100
2
Cleared 510(K)
K
05
1988
OXY-SERVE II OXYGEN CONSERVING REGULATOR
2
Cleared 510(K)
K
05
1540
INOVO, INC. INDEPENDENCE OXYGEN CONSERVING REGULATOR
2
Cleared 510(K)
K
05
1007
ACCU02 SYSTEM
2
Cleared 510(K)
K
04
2142
CHAD THERAPEUTICS LOTUS, MODELS OM-700 AND OM-700S
2
Cleared 510(K)
K
04
1057
FLO-RITE
2
Cleared 510(K)
K
04
1568
EOCD
2
Cleared 510(K)
K
03
3197
INOGEN SATELLITE CONSERVER
2
Cleared 510(K)
K
03
3364
CHAD THERAPEUTICS SAGE
2
Cleared 510(K)
K
02
4023
ESSEX HIGH PRESSURE (HP) OCD AND ESSEX ESCORT PNEUMATIC CONSERVER
2
Cleared 510(K)
K
03
1983
INOVO, INC, ECONOMIZER CONSERVING REGULATOR
2
Cleared 510(K)
K
03
2018
EASY PULSE II OXYGEN CONSERVER
2
Cleared 510(K)
K
02
3673
AIRLIFE DEMAND NASAL CANNULA
2
Cleared 510(K)
K
02
2865
6203
2
Cleared 510(K)
K
02
3420
PULSED OXYGEN CONSERVING DEVICE - EVERY BREATH, POCDEB, REACTEB
2
Cleared 510(K)
K
02
0475
CHAD THERAPEUTICS OXYPENUMATIC CYPRESS MODEL 511
2
Cleared 510(K)
K
02
0329
DEVILBISS PD1000
2
Cleared 510(K)
K
01
0747
OPC OXYGEN CONSERVING REGULATOR, MODEL AHG 1968, LIN-7005, MDL-7609, MEM-7612, OPC-830
2
Cleared 510(K)
K
01
0389
CHAD THERAPEUTICS OXYMATIC MODEL 401 AND OXYMATIC MODEL 411
2
Cleared 510(K)
K
00
1412
PM 1800 CONSERVING DEVICE
2
Cleared 510(K)
K
00
3455
MODIFICATION TO CHAD THERAPEUTICS OXYMATIC MODEL 401
2
Cleared 510(K)
K
00
2284
VENTURE IDD OXYGEN CONSERVING DEVICE IDD 20EX AND 50EX
2
Cleared 510(K)
K
00
1579
IMPULSE SELECT
2
Cleared 510(K)
K
99
2935
OCD2001
2
Cleared 510(K)
K
00
0890
CHAD THERAPEUTICS OXYMATIC MODEL 401
2
Cleared 510(K)
K
99
2659
O2N DEMAND-II, VICTOR MODEL OCPR-II
2
Cleared 510(K)
K
98
2943
TRANSTRACHEAL DEMAND OXYGEN CONTROLLER MODEL DOC-3000
2
Cleared 510(K)
K
99
0678
PNEUMATIC DEMAND OXYGEN CONSERVER (PDOC)
2
Cleared 510(K)
K
98
3601
DEMAND OXYGEN CONSERVING DEVICE, DOCD, THE DOC
2
Cleared 510(K)
K
98
3459
PULSED OXYGEN CONSERVING DEVICE, POCD
2
Cleared 510(K)
K
96
4541
SANPO I
2
Cleared 510(K)
K
97
0371
FLOTEC OXYSAVRR (S)
2
Cleared 510(K)
K
96
3247
VICTOR MODEL OCPR OXYGEN CONSERVING PRESSURE REGULATOR
2
Cleared 510(K)
K
96
2944
TRANSTRACHEAL DEMAND OXYGEN CONTROLLER (DOC-2000)
2
Cleared 510(K)
K
96
1126
PULSE DOSE SERIES
2
Cleared 510(K)
K
96
2766
AIRSEP IMPULSE
2
Cleared 510(K)
K
95
5129
OXYPULSE EOC I, EOC II & EOC R
2
Cleared 510(K)
K
95
3852
MODEL IPD OXYGEN CONSERVING DEVICE
2
Cleared 510(K)
K
92
3660
MEDISONIC OXYGEN FLOW CONTROLLER
2
Cleared 510(K)
K
90
3504
HALA'TUS 1 OXYGENATOR
2
Cleared 510(K)
K
89
2639
THE ORIGINAL PULSE-PAK
2
Cleared 510(K)
K
89
2407
MODIFIED DEMAND NASAL OXYGEN CANNULA
2
Cleared 510(K)
K
89
0141
DEVILBISS MODEL 1400D (OXYGEN CONSERVING DEVICE)
2
Cleared 510(K)
K
89
0298
DEMAND NASAL OXYGEN CANNULA MODELS 4008/4108/4208
2
Cleared 510(K)
K
88
4562
OXYMATIC-24
2
Cleared 510(K)
K
88
4754
VOYAGER/X
2
Cleared 510(K)
K
88
3590
OXYTROL
2
Cleared 510(K)
K
88
3216
BUNN MODEL 50 OXYGEN FLOW CONTROLLER
2
Cleared 510(K)
K
87
4804
OXYGEN SUPPLY CONTROL REGULATOR (OSCR)
2
Cleared 510(K)
K
87
3901
COMPANION MINI OXYGEN SAVER
2
Cleared 510(K)
K
86
4127
MECHANICAL OXYGEN REGULATOR
2
Cleared 510(K)
K
86
3695
COMPANION OXYGEN SAVER
2
Cleared 510(K)
K
86
1325
MAXI-USE O2 DEVICE
2
Cleared 510(K)
K
86
1199
BUNN MODEL 22 OXYGEN FLOW CONTROLLER
2
Cleared 510(K)
K
85
3378
AUTO PRO
2
Cleared 510(K)
K
85
2650
OXYMATICTM ELECTRONIC OXGYEN CONSERVER
2
Cleared 510(K)
K
85
1235
DEMAND OXYGEN SAUER DOS2 MODEL 10
2
Cleared 510(K)
K
83
4588
OXYMIZER-PENDANT
2
Cleared 510(K)
K
83
0009
OXYMIZER
2
Cleared 510(K)
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
/
NFB
/
K851235
View Source
DEMAND OXYGEN SAUER DOS2 MODEL 10
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K851235
510(k) Type
Traditional
Applicant
APPLIED MEMBRANE TECHNOLOGY, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/30/1985
Days to Decision
35 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)
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
K
22
0591
Proxima
K
22
1014
Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile
K
20
0401
Apogee
K
15
1506
Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula
K
13
1023
THERAFLOW SINGLE LUMEN AND THERAFLOW DUAL LUMEN
K
11
3111
CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER WITH MOTION
K
10
3392
CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER
K
09
0421
MODEL 350G GAS CONSERVER
K
07
0740
CHAD THERAPEUTICS BONSAI MODEL 800
K
06
0751
INOVO, INC. ACCUPULSE SINGLE LUMEN CONSERVING REGULATOR
K
06
0382
FLO-RITE, MODEL 478-1; FLO-RITE II, MODEL 478-1; SIMPULSE II, MODEL 478-2S; NUMATIX, MODEL NCD401; SIMPULSE, MODEL 478-1
K
05
2563
INOGEN SATELLITE CONSERVER, MODEL SC-100
K
05
1988
OXY-SERVE II OXYGEN CONSERVING REGULATOR
K
05
1540
INOVO, INC. INDEPENDENCE OXYGEN CONSERVING REGULATOR
K
05
1007
ACCU02 SYSTEM
K
04
2142
CHAD THERAPEUTICS LOTUS, MODELS OM-700 AND OM-700S
K
04
1057
FLO-RITE
K
04
1568
EOCD
K
03
3197
INOGEN SATELLITE CONSERVER
K
03
3364
CHAD THERAPEUTICS SAGE
K
02
4023
ESSEX HIGH PRESSURE (HP) OCD AND ESSEX ESCORT PNEUMATIC CONSERVER
K
03
1983
INOVO, INC, ECONOMIZER CONSERVING REGULATOR
K
03
2018
EASY PULSE II OXYGEN CONSERVER
K
02
3673
AIRLIFE DEMAND NASAL CANNULA
K
02
2865
6203
K
02
3420
PULSED OXYGEN CONSERVING DEVICE - EVERY BREATH, POCDEB, REACTEB
K
02
0475
CHAD THERAPEUTICS OXYPENUMATIC CYPRESS MODEL 511
K
02
0329
DEVILBISS PD1000
K
01
0747
OPC OXYGEN CONSERVING REGULATOR, MODEL AHG 1968, LIN-7005, MDL-7609, MEM-7612, OPC-830
K
01
0389
CHAD THERAPEUTICS OXYMATIC MODEL 401 AND OXYMATIC MODEL 411
K
00
1412
PM 1800 CONSERVING DEVICE
K
00
3455
MODIFICATION TO CHAD THERAPEUTICS OXYMATIC MODEL 401
K
00
2284
VENTURE IDD OXYGEN CONSERVING DEVICE IDD 20EX AND 50EX
K
00
1579
IMPULSE SELECT
K
99
2935
OCD2001
K
00
0890
CHAD THERAPEUTICS OXYMATIC MODEL 401
K
99
2659
O2N DEMAND-II, VICTOR MODEL OCPR-II
K
98
2943
TRANSTRACHEAL DEMAND OXYGEN CONTROLLER MODEL DOC-3000
K
99
0678
PNEUMATIC DEMAND OXYGEN CONSERVER (PDOC)
K
98
3601
DEMAND OXYGEN CONSERVING DEVICE, DOCD, THE DOC
K
98
3459
PULSED OXYGEN CONSERVING DEVICE, POCD
K
96
4541
SANPO I
K
97
0371
FLOTEC OXYSAVRR (S)
K
96
3247
VICTOR MODEL OCPR OXYGEN CONSERVING PRESSURE REGULATOR
K
96
2944
TRANSTRACHEAL DEMAND OXYGEN CONTROLLER (DOC-2000)
K
96
1126
PULSE DOSE SERIES
K
96
2766
AIRSEP IMPULSE
K
95
5129
OXYPULSE EOC I, EOC II & EOC R
K
95
3852
MODEL IPD OXYGEN CONSERVING DEVICE
K
92
3660
MEDISONIC OXYGEN FLOW CONTROLLER
K
90
3504
HALA'TUS 1 OXYGENATOR
K
89
2639
THE ORIGINAL PULSE-PAK
K
89
2407
MODIFIED DEMAND NASAL OXYGEN CANNULA
K
89
0141
DEVILBISS MODEL 1400D (OXYGEN CONSERVING DEVICE)
K
89
0298
DEMAND NASAL OXYGEN CANNULA MODELS 4008/4108/4208
K
88
4562
OXYMATIC-24
K
88
4754
VOYAGER/X
K
88
3590
OXYTROL
K
88
3216
BUNN MODEL 50 OXYGEN FLOW CONTROLLER
K
87
4804
OXYGEN SUPPLY CONTROL REGULATOR (OSCR)
K
87
3901
COMPANION MINI OXYGEN SAVER
K
86
4127
MECHANICAL OXYGEN REGULATOR
K
86
3695
COMPANION OXYGEN SAVER
K
86
1325
MAXI-USE O2 DEVICE
K
86
1199
BUNN MODEL 22 OXYGEN FLOW CONTROLLER
K
85
3378
AUTO PRO
K
85
2650
OXYMATICTM ELECTRONIC OXGYEN CONSERVER
K
85
1235
DEMAND OXYGEN SAUER DOS2 MODEL 10
K
83
4588
OXYMIZER-PENDANT
K
83
0009
OXYMIZER
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
/
NFB
/
K851235
View Source
DEMAND OXYGEN SAUER DOS2 MODEL 10
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K851235
510(k) Type
Traditional
Applicant
APPLIED MEMBRANE TECHNOLOGY, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/30/1985
Days to Decision
35 days