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Innolitics
Anesthesiology
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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
CAP
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
2
Product Code
CAX
Flowmeter, Tube, Thorpe, Back-Pressure Compensated
1
Product Code
K
92
3781
MXR-2000 FLOWMETER
1
Cleared 510(K)
K
91
0316
OHMEDA - LOW FLOW FLOWMETER
1
Cleared 510(K)
K
88
4973
FR6000 FLOWMETER
1
Cleared 510(K)
K
87
2718
SERIES D FLOWMETER
1
Cleared 510(K)
K
87
1452
CLASSIC (TM) 200 OXYGEN FLOWMETER
1
Cleared 510(K)
K
86
2797
AIRCO 2000 SERIES FLOWMETERS
1
Cleared 510(K)
K
85
4067
SELECT FLOWMETER
1
Cleared 510(K)
K
85
1288
OXYGEN DELIVERY MEASURING DEVICE
1
Cleared 510(K)
K
85
0559
PRESSURE RELIEF ADAPTOR
1
Cleared 510(K)
K
85
0560
FLOWMETER, BACKPRESSURE COMPENSATED, THORPE TUBE
1
Cleared 510(K)
K
83
4260
RECON-2 FLOW CONTROLLER
1
Cleared 510(K)
K
81
2419
PRESET FLOWMETER
1
Cleared 510(K)
K
81
2183
TIMETER-PRODUCED PURITAN BENNETT AIR ADP
1
Cleared 510(K)
K
81
2128
RECON 1
1
Cleared 510(K)
K
80
2659
RESPIRATORY THERAPY FLOWMETER
1
Cleared 510(K)
K
80
2311
MO8 OXYGEN FLOWMETER
1
Cleared 510(K)
K
79
1900
M015 OXYGEN & MA15 AIR
1
Cleared 510(K)
K
79
1648
MODEL 54 FLOWMETER BACK-PRESSURE TUBE
1
Cleared 510(K)
K
79
1220
FLOWMETER, BACK PRESSURE COMPENSATED,
1
Cleared 510(K)
K
79
1017
FLOW LIMITER
1
Cleared 510(K)
K
79
1069
LINDE OXYGEN THERAPY FLOWMETERS, L33-L34
1
Cleared 510(K)
K
78
1541
FLOMETER
1
Cleared 510(K)
K
76
0314
FLOWMETER, OXYGEN
1
Cleared 510(K)
K
76
0102
FLOWMETER, P.C., REDESIGNED VERSION
1
Cleared 510(K)
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
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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 6 December 2024 at 11:05 pm
AN
/
subpart-c—monitoring-devices
/
CAX
/
K802311
View Source
MO8 OXYGEN FLOWMETER
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K802311
510(k) Type
Traditional
Applicant
TIMETER INSTRUMENT CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/23/1980
Days to Decision
30 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
CAP
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
CAX
Flowmeter, Tube, Thorpe, Back-Pressure Compensated
K
92
3781
MXR-2000 FLOWMETER
K
91
0316
OHMEDA - LOW FLOW FLOWMETER
K
88
4973
FR6000 FLOWMETER
K
87
2718
SERIES D FLOWMETER
K
87
1452
CLASSIC (TM) 200 OXYGEN FLOWMETER
K
86
2797
AIRCO 2000 SERIES FLOWMETERS
K
85
4067
SELECT FLOWMETER
K
85
1288
OXYGEN DELIVERY MEASURING DEVICE
K
85
0559
PRESSURE RELIEF ADAPTOR
K
85
0560
FLOWMETER, BACKPRESSURE COMPENSATED, THORPE TUBE
K
83
4260
RECON-2 FLOW CONTROLLER
K
81
2419
PRESET FLOWMETER
K
81
2183
TIMETER-PRODUCED PURITAN BENNETT AIR ADP
K
81
2128
RECON 1
K
80
2659
RESPIRATORY THERAPY FLOWMETER
K
80
2311
MO8 OXYGEN FLOWMETER
K
79
1900
M015 OXYGEN & MA15 AIR
K
79
1648
MODEL 54 FLOWMETER BACK-PRESSURE TUBE
K
79
1220
FLOWMETER, BACK PRESSURE COMPENSATED,
K
79
1017
FLOW LIMITER
K
79
1069
LINDE OXYGEN THERAPY FLOWMETERS, L33-L34
K
78
1541
FLOMETER
K
76
0314
FLOWMETER, OXYGEN
K
76
0102
FLOWMETER, P.C., REDESIGNED VERSION
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
/
CAX
/
K802311
View Source
MO8 OXYGEN FLOWMETER
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K802311
510(k) Type
Traditional
Applicant
TIMETER INSTRUMENT CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/23/1980
Days to Decision
30 days