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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
BXH
Gauge, Gas Pressure, Cylinder/Pipeline
1
Product Code
BXM
Stimulator, Nerve, Ac-Powered
2
Product Code
BXN
Stimulator, Nerve, Battery-Powered
2
Product Code
BXO
Transducer, Gas Pressure
1
Product Code
BXP
Transducer, Gas Flow
1
Product Code
BXX
Calibrator, Pressure, Gas
1
Product Code
BXY
Flowmeter, Calibration, Gas
1
Product Code
BYM
Tube, Thorpe, Uncompensated
1
Product Code
BYR
Transducer, Gas Pressure, Differential
1
Product Code
BZQ
Monitor, Breathing Frequency
2
Product Code
CAN
Regulator, Pressure, Gas Cylinder
1
Product Code
K
16
2811
MR Conditional CGA 870
1
Cleared 510(K)
K
08
0243
PORTABLE OXYGEN UNIT SCA900
1
Cleared 510(K)
K
06
0265
REMCORE REMOTE CONTROLLED OXYGEN REGULATOR
1
Cleared 510(K)
K
06
1785
CYL-FIL OXYGEN SYSTEM
1
Cleared 510(K)
K
95
0777
OXYGEN REGULATOR
1
Cleared 510(K)
K
94
2751
VANGUARD SERIES GAS REGULATORS
1
Cleared 510(K)
K
93
6187
LSPI PRESSURE REGULATOR
1
Cleared 510(K)
K
93
2006
1500 SERIES REGULATOR
1
Cleared 510(K)
K
92
1125
AMBU OXYGEN REGULATOR
1
Cleared 510(K)
K
91
5154
GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELS
1
Cleared 510(K)
K
91
5505
REGULATOR FLOWMETER
1
Cleared 510(K)
K
91
4271
GAMBRO ENGSTROM Y-FILTER WITH EDITH FLEX (1500F)
1
Cleared 510(K)
K
91
2174
SALTER LABS DISPOSABLE NIPPLE AND NUT
1
Cleared 510(K)
K
90
1831
PRECISION MEDICAL OXYGEN REGULATOR
1
Cleared 510(K)
K
90
1623
AMBU OXYGEN REGULATOR
1
Cleared 510(K)
K
89
5956
RX02 EMERGENCY MEDICAL OXYGEN
1
Cleared 510(K)
K
90
0115
VENTLAB EXHALATION MANIFOLD VX-2000 A & VX-2000 B
1
Cleared 510(K)
K
89
6152
PURITAN-BENNETT OXYGEN PRESSURE REGULATOR W/FLOW.
1
Cleared 510(K)
K
89
6128
PURITAN-BENNETT OXYGEN PRESSURE REGULATOR
1
Cleared 510(K)
K
89
4850
8053 TWO STAGE TYPE A-B NITROUS OXIDE THERAPY CYLI
1
Cleared 510(K)
K
89
4302
OXYGEN THERAPY REGULATOR
1
Cleared 510(K)
K
89
3621
CONCOA PRESSURE REGULATORS
1
Cleared 510(K)
K
89
1771
VICTOR MEDICAL OXYGEN THERAPY REGULATOR, MODIFIED
1
Cleared 510(K)
K
88
4927
BE #1100 MOISTURE TRAP & BE #1102/50 DISP CANISTER
1
Cleared 510(K)
K
88
3483
AUTOFLOW PART NUMBER PR3241-420 PRESSURE REGULATOR
1
Cleared 510(K)
K
87
2170
CRT PORTABLE EMERGENCY OXYGEN INHALATOR
1
Cleared 510(K)
K
86
5077
ACCU-FLO REGULATOR
1
Cleared 510(K)
K
86
3711
REGULATOR OXYGEN MECHANICAL
1
Cleared 510(K)
K
86
2796
AIRCO PRESSURE REGULATORS
1
Cleared 510(K)
K
86
2193
# 10099/10225/10235/10275/10525/10625/10715/10125
1
Cleared 510(K)
K
85
3039
PRESSURE REGULATOR
1
Cleared 510(K)
K
86
1166
OXYGEN THERAPY REGULATOR OR REGULATOR-FLOWMETER
1
Cleared 510(K)
K
85
2333
DOWNS VPAP CIRCUIT
1
Cleared 510(K)
K
85
2663
PORTABLE GASEOUS OXGYEN CONTAINER
1
Cleared 510(K)
K
85
2649
PRESSURE REGULATOR/Y CONNECTOR
1
Cleared 510(K)
K
85
2374
OXYGEN REGULATORS #50 PRT & BGT(BGT15,BGT18
1
Cleared 510(K)
K
84
4622
SAV-A-LIFE
1
Cleared 510(K)
K
85
0106
AIRCO NITROUS OXIDE REGULATOR
1
Cleared 510(K)
K
84
3585
BEMCO PORTABLE OXYGEN INHALATOR
1
Cleared 510(K)
K
84
1367
AIRCO OXYGEN REGULATOR
1
Cleared 510(K)
K
83
4061
SLO-FLO 40AL ADJUST-FLOW REGULATOR
1
Cleared 510(K)
K
83
0844
PORTABLE OXYGEN SYSTEM
1
Cleared 510(K)
K
81
3467
2002 ADJUSTABLE FLOW REGULATOR
1
Cleared 510(K)
K
81
3466
4004 CONSTANT FLOW REGULATOR
1
Cleared 510(K)
K
81
1430
ANESTHESIOLOGY DEVICE
1
Cleared 510(K)
K
81
0679
MS-303-OXYGEN REGULATOR SHIELD
1
Cleared 510(K)
K
81
0132
MODEL 2 FLOWMETER
1
Cleared 510(K)
K
80
3207
REGULATOR, OXYGEN MECHANICAL
1
Cleared 510(K)
K
80
2644
EMERG. OXYGEN KIT #65350 & #65399 CASE
1
Cleared 510(K)
K
78
0750
O2 CONNECTOR
1
Cleared 510(K)
K
78
0359
OXYGEN REGULATOR/FLOWMETER
1
Cleared 510(K)
K
78
0364
MANIFOLD KIT
1
Cleared 510(K)
K
78
0084
OXYGEN THERAPY KIT
1
Cleared 510(K)
K
77
2216
PORT-A-BOUT 240
1
Cleared 510(K)
K
77
1241
SPIR-E-VAC
1
Cleared 510(K)
CAP
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
2
Product Code
CAX
Flowmeter, Tube, Thorpe, Back-Pressure Compensated
1
Product Code
CBA
Monitor, Air Embolism, Ultrasonic
2
Product Code
CCN
Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge
1
Product Code
ECX
Cylinder, Compressed Gas, And Valve
1
Product Code
FLS
Monitor, Apnea, Facility Use
2
Product Code
JAX
Pneumotachometer
2
Product Code
JEZ
Monitor, Lung Water Measurement
3
Product Code
KLK
Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
2
Product Code
KOI
Stimulator, Nerve, Peripheral, Electric
2
Product Code
LKD
Monitor, Carbon-Dioxide, Cutaneous
2
Product Code
LPP
Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia
2
Product Code
MNR
Ventilatory Effort Recorder
2
Product Code
MRP
Analyzer, Nitric Oxide
2
Product Code
MRQ
Analyzer, Nitrogen Dioxide
2
Product Code
NPF
Monitor, Apnea, Home Use
2
Product Code
PRK
Device Indicating An Exhalation Event
2
Product Code
PUG
Analyzer, Nitrogen Dioxide, Exempt
2
Product Code
PXE
Pressure Monitoring (Air/Gas) Kit
1
Product Code
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
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-c—monitoring-devices
/
CAN
/
K803207
View Source
REGULATOR, OXYGEN MECHANICAL
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K803207
510(k) Type
Traditional
Applicant
TIMETER INSTRUMENT CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/15/1981
Days to Decision
28 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
BXH
Gauge, Gas Pressure, Cylinder/Pipeline
BXM
Stimulator, Nerve, Ac-Powered
BXN
Stimulator, Nerve, Battery-Powered
BXO
Transducer, Gas Pressure
BXP
Transducer, Gas Flow
BXX
Calibrator, Pressure, Gas
BXY
Flowmeter, Calibration, Gas
BYM
Tube, Thorpe, Uncompensated
BYR
Transducer, Gas Pressure, Differential
BZQ
Monitor, Breathing Frequency
CAN
Regulator, Pressure, Gas Cylinder
K
16
2811
MR Conditional CGA 870
K
08
0243
PORTABLE OXYGEN UNIT SCA900
K
06
0265
REMCORE REMOTE CONTROLLED OXYGEN REGULATOR
K
06
1785
CYL-FIL OXYGEN SYSTEM
K
95
0777
OXYGEN REGULATOR
K
94
2751
VANGUARD SERIES GAS REGULATORS
K
93
6187
LSPI PRESSURE REGULATOR
K
93
2006
1500 SERIES REGULATOR
K
92
1125
AMBU OXYGEN REGULATOR
K
91
5154
GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELS
K
91
5505
REGULATOR FLOWMETER
K
91
4271
GAMBRO ENGSTROM Y-FILTER WITH EDITH FLEX (1500F)
K
91
2174
SALTER LABS DISPOSABLE NIPPLE AND NUT
K
90
1831
PRECISION MEDICAL OXYGEN REGULATOR
K
90
1623
AMBU OXYGEN REGULATOR
K
89
5956
RX02 EMERGENCY MEDICAL OXYGEN
K
90
0115
VENTLAB EXHALATION MANIFOLD VX-2000 A & VX-2000 B
K
89
6152
PURITAN-BENNETT OXYGEN PRESSURE REGULATOR W/FLOW.
K
89
6128
PURITAN-BENNETT OXYGEN PRESSURE REGULATOR
K
89
4850
8053 TWO STAGE TYPE A-B NITROUS OXIDE THERAPY CYLI
K
89
4302
OXYGEN THERAPY REGULATOR
K
89
3621
CONCOA PRESSURE REGULATORS
K
89
1771
VICTOR MEDICAL OXYGEN THERAPY REGULATOR, MODIFIED
K
88
4927
BE #1100 MOISTURE TRAP & BE #1102/50 DISP CANISTER
K
88
3483
AUTOFLOW PART NUMBER PR3241-420 PRESSURE REGULATOR
K
87
2170
CRT PORTABLE EMERGENCY OXYGEN INHALATOR
K
86
5077
ACCU-FLO REGULATOR
K
86
3711
REGULATOR OXYGEN MECHANICAL
K
86
2796
AIRCO PRESSURE REGULATORS
K
86
2193
# 10099/10225/10235/10275/10525/10625/10715/10125
K
85
3039
PRESSURE REGULATOR
K
86
1166
OXYGEN THERAPY REGULATOR OR REGULATOR-FLOWMETER
K
85
2333
DOWNS VPAP CIRCUIT
K
85
2663
PORTABLE GASEOUS OXGYEN CONTAINER
K
85
2649
PRESSURE REGULATOR/Y CONNECTOR
K
85
2374
OXYGEN REGULATORS #50 PRT & BGT(BGT15,BGT18
K
84
4622
SAV-A-LIFE
K
85
0106
AIRCO NITROUS OXIDE REGULATOR
K
84
3585
BEMCO PORTABLE OXYGEN INHALATOR
K
84
1367
AIRCO OXYGEN REGULATOR
K
83
4061
SLO-FLO 40AL ADJUST-FLOW REGULATOR
K
83
0844
PORTABLE OXYGEN SYSTEM
K
81
3467
2002 ADJUSTABLE FLOW REGULATOR
K
81
3466
4004 CONSTANT FLOW REGULATOR
K
81
1430
ANESTHESIOLOGY DEVICE
K
81
0679
MS-303-OXYGEN REGULATOR SHIELD
K
81
0132
MODEL 2 FLOWMETER
K
80
3207
REGULATOR, OXYGEN MECHANICAL
K
80
2644
EMERG. OXYGEN KIT #65350 & #65399 CASE
K
78
0750
O2 CONNECTOR
K
78
0359
OXYGEN REGULATOR/FLOWMETER
K
78
0364
MANIFOLD KIT
K
78
0084
OXYGEN THERAPY KIT
K
77
2216
PORT-A-BOUT 240
K
77
1241
SPIR-E-VAC
CAP
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
CAX
Flowmeter, Tube, Thorpe, Back-Pressure Compensated
CBA
Monitor, Air Embolism, Ultrasonic
CCN
Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge
ECX
Cylinder, Compressed Gas, And Valve
FLS
Monitor, Apnea, Facility Use
JAX
Pneumotachometer
JEZ
Monitor, Lung Water Measurement
KLK
Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
KOI
Stimulator, Nerve, Peripheral, Electric
LKD
Monitor, Carbon-Dioxide, Cutaneous
LPP
Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia
MNR
Ventilatory Effort Recorder
MRP
Analyzer, Nitric Oxide
MRQ
Analyzer, Nitrogen Dioxide
NPF
Monitor, Apnea, Home Use
PRK
Device Indicating An Exhalation Event
PUG
Analyzer, Nitrogen Dioxide, Exempt
PXE
Pressure Monitoring (Air/Gas) Kit
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
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-c—monitoring-devices
/
CAN
/
K803207
View Source
REGULATOR, OXYGEN MECHANICAL
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K803207
510(k) Type
Traditional
Applicant
TIMETER INSTRUMENT CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/15/1981
Days to Decision
28 days