FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
BSE
Analyzer, Gas, Helium, Gaseous-Phase
2
Product Code
BSI
Algesimeter, Powered
2
Product Code
BTY
Calculator, Predicted Values, Pulmonary Function
2
Product Code
BXA
Analyzer, Gas, Water Vapor, Gaseous-Phase
1
Product Code
BXL
Algesimeter, Manual
1
Product Code
BXQ
Rhinoanemometer (Measurement Of Nasal Decongestion)
2
Product Code
BXR
Meter, Airway Pressure (Inspiratory Force)
2
Product Code
BXW
Calibrator, Volume, Gas
1
Product Code
BZC
Calculator, Pulmonary Function Data
2
Product Code
BZG
Spirometer, Diagnostic
2
Product Code
BZH
Meter, Peak Flow, Spirometry
2
Product Code
BZK
Spirometer, Monitoring (W/Wo Alarm)
2
Product Code
BZL
Computer, Oxygen-Uptake
2
Product Code
BZM
Calculator, Pulmonary Function Interpretor (Diagnostic)
2
Product Code
BZS
Stethoscope Head
1
Product Code
BZT
Stethoscope, Esophageal, With Electrical Conductors
2
Product Code
BZW
Stethoscope, Esophageal
1
Product Code
CBQ
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
2
Product Code
CBR
Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
2
Product Code
CBS
Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
2
Product Code
CBT
Arterial Blood Sampling Kit
1
Product Code
K
07
1269
HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEM
1
Cleared 510(K)
K
07
0340
SECURE ARTERIAL BLOOD SAMPLING SYSTEM
1
Cleared 510(K)
K
95
5663
ABC IN-LINE BLOOD SAMPLING KIT
1
Cleared 510(K)
K
95
4015
ABG POINT LOK NEEDLE PROTECTION DEVICE
1
Cleared 510(K)
K
95
4035
ACTI-FLEX ARTERIAL EXTENSION SET
1
Cleared 510(K)
K
95
0098
NEEDLE SAFETY COVER
1
Cleared 510(K)
K
94
5719
ASPIR-PULSE(TM) ARTERIAL BLOOD GAS (ABG) SYSTEM
1
Cleared 510(K)
K
94
4941
PISTON SYRINGE
1
Cleared 510(K)
K
94
5485
ABG NEEDLE PROTECTION
1
Cleared 510(K)
K
94
0575
ASPIR-PULSE(TM) SAF-T-VENT
1
Cleared 510(K)
K
93
1873
VACVENT
1
Cleared 510(K)
K
93
0986
BLOOD GAS KIT (NON-STERILE) REORDER NO. 0560
1
Cleared 510(K)
K
92
5453
SHERWOOD MEDICAL ARTERIAL BLOOD GAS KIT I
1
Cleared 510(K)
K
93
0471
SHERWOOD MEDICAL ARTERIAL BLOOD GAS KIT II
1
Cleared 510(K)
K
93
0286
DRI-VENDT/PROVENT/ACCUVENT ARTERIAL BLOOD GAS KITS
1
Cleared 510(K)
K
91
4778
NEOLINE(TM)
1
Cleared 510(K)
K
91
2043
ACCU-VENT(TM) WITH NEEDLE-PRO(TM)
1
Cleared 510(K)
K
90
5464
MEDICAL PROCEDURE KITS/ARTERIAL BLOOD SAMPLING
1
Cleared 510(K)
K
90
2881
LAB-SITE SAFETY NEEDLE
1
Cleared 510(K)
K
90
2632
GAS-LYTE 1CC AND 3CC ARTERIAL BLOOD SAMPLERS
1
Cleared 510(K)
K
90
0302
UMBILICAL CORD BLOOD SAMPLING KIT
1
Cleared 510(K)
K
89
7133
MODEL 1050 - UMBILICAL CORD BLOOD SAMPLING KIT
1
Cleared 510(K)
K
89
5171
BLOOD GAS SAFETY SYRINGE
1
Cleared 510(K)
K
87
5117
CIBA CORNING BALANCED HEPARIN FOR CA++
1
Cleared 510(K)
K
87
2244
CORD-ASSURE UMBILICAL BLOOD GAS KIT
1
Cleared 510(K)
K
87
0720
AIRLIFE ARTERIAL BLOOD GAS SAMPLING SYRINGE
1
Cleared 510(K)
K
84
4615
BIOSAMPLER
1
Cleared 510(K)
K
84
3360
ARTAP ARTERIAL BLOOD SAMPLING DEVICE
1
Cleared 510(K)
K
84
2008
MARQUEST MICRO STIK 9000 SERIES
1
Cleared 510(K)
K
84
1486
ARTERIAL BLOOD SAMPLING KITS
1
Cleared 510(K)
K
84
0986
PREFILLED PULSATOR SYRINGE
1
Cleared 510(K)
K
84
0987
VAPORIZED HEPARIN
1
Cleared 510(K)
K
83
3923
MARZ-175 ARTERIAL BLOOD GAS SYRINGE
1
Cleared 510(K)
K
83
3582
PULSATOR ARTERIAL BLOOD SAMPLING SYRIN
1
Cleared 510(K)
K
83
2545
ARTERIAL BLOOD SAMPLING KIT
1
Cleared 510(K)
K
83
0310
OMNISTICK
1
Cleared 510(K)
K
83
0311
AUTO STIK
1
Cleared 510(K)
K
83
0312
ASPIRATOR
1
Cleared 510(K)
K
83
1034
QUALISTICK ARTERIAL BLOOD SAMPLER
1
Cleared 510(K)
K
83
0333
ABG KITS - CMS 4000 SERIES
1
Cleared 510(K)
K
82
2786
MDM ARTERIAL BLOOD GAS KIT
1
Cleared 510(K)
K
82
2248
DESERET ARTERIAL BLOOD SAMPLING KIT
1
Cleared 510(K)
K
82
1406
ARTERIAL BLOOD SAMPLING KIT
1
Cleared 510(K)
K
82
0875
AUTOSTIK
1
Cleared 510(K)
K
81
2338
PREZA-PAK II, ARTERIAL BLOOD SAMPLING SY
1
Cleared 510(K)
K
81
1860
EASY-FLO ARTERIAL BLOOD GAS KIT
1
Cleared 510(K)
K
81
1199
MARZ-175
1
Cleared 510(K)
K
80
1620
ASPIRATOR
1
Cleared 510(K)
K
80
1435
ORGANON ARTERIAL BLOOD SAMPLER
1
Cleared 510(K)
K
80
1146
SAMPLING KIT
1
Cleared 510(K)
K
80
0860
OMNISTIK, MQ 501GS
1
Cleared 510(K)
K
79
1465
MOSQUITO ARTERIAL BLOOD SAMPLER
1
Cleared 510(K)
K
79
0196
MONOJECT ARTERIAL BLOOD SAMPLING DEVICE
1
Cleared 510(K)
K
78
1857
TRAY, ARTERIAL BLOOD GAS SAMPLING
1
Cleared 510(K)
K
78
1616
OMNI STIK
1
Cleared 510(K)
K
78
0939
BARD-PARKER ARTERIAL MONITORING SYSTEM
1
Cleared 510(K)
K
77
1975
ARTERIAL BLOOD SAMPLING TRAY
1
Cleared 510(K)
K
77
1013
MOSQUITO
1
Cleared 510(K)
CBZ
Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling
2
Product Code
CCC
Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling
2
Product Code
CCE
Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling
2
Product Code
CCI
Analyzer, Gas, Nitrogen, Gaseous-Phase
2
Product Code
CCJ
Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
2
Product Code
CCK
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
2
Product Code
CCL
Analyzer, Gas, Oxygen, Gaseous-Phase
2
Product Code
CCM
Plethysmograph, Pressure
2
Product Code
JED
Analyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling
3
Product Code
JEF
Analyzer, Gas, Neon, Gaseous-Phase
2
Product Code
JEG
Analyzer, Gas, Argon, Gaseous-Phase
2
Product Code
JEH
Plethysmograph, Volume
2
Product Code
JFE
Valve, Switching (Ploss)
1
Product Code
KGK
Gas, Collecting Vessel
1
Product Code
NHO
Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)
2
Product Code
NHP
Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)
2
Product Code
NHQ
Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)
2
Product Code
OFZ
Blood Specimen Collection Kit (Excludes Hiv Testing)
1
Product Code
PNV
Impedance Measuring Device Utilizing Oscillation Techniques
2
Product Code
OGK
Orotracheal Intubation Guide Kit
2
Product Code
PHZ
Abnormal Breath Sound Device
2
Product Code
QEB
Ventilatory Electrical Impedance Tomograph
2
Product Code
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
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-b—diagnostic-devices
/
CBT
/
K830333
View Source
ABG KITS - CMS 4000 SERIES
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K830333
510(k) Type
Traditional
Applicant
CURRIE MEDICAL SPECIALTIES, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/31/1983
Days to Decision
58 days
FDA Browser
by
Innolitics
Anesthesiology
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
BSE
Analyzer, Gas, Helium, Gaseous-Phase
BSI
Algesimeter, Powered
BTY
Calculator, Predicted Values, Pulmonary Function
BXA
Analyzer, Gas, Water Vapor, Gaseous-Phase
BXL
Algesimeter, Manual
BXQ
Rhinoanemometer (Measurement Of Nasal Decongestion)
BXR
Meter, Airway Pressure (Inspiratory Force)
BXW
Calibrator, Volume, Gas
BZC
Calculator, Pulmonary Function Data
BZG
Spirometer, Diagnostic
BZH
Meter, Peak Flow, Spirometry
BZK
Spirometer, Monitoring (W/Wo Alarm)
BZL
Computer, Oxygen-Uptake
BZM
Calculator, Pulmonary Function Interpretor (Diagnostic)
BZS
Stethoscope Head
BZT
Stethoscope, Esophageal, With Electrical Conductors
BZW
Stethoscope, Esophageal
CBQ
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
CBR
Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
CBS
Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
CBT
Arterial Blood Sampling Kit
K
07
1269
HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEM
K
07
0340
SECURE ARTERIAL BLOOD SAMPLING SYSTEM
K
95
5663
ABC IN-LINE BLOOD SAMPLING KIT
K
95
4015
ABG POINT LOK NEEDLE PROTECTION DEVICE
K
95
4035
ACTI-FLEX ARTERIAL EXTENSION SET
K
95
0098
NEEDLE SAFETY COVER
K
94
5719
ASPIR-PULSE(TM) ARTERIAL BLOOD GAS (ABG) SYSTEM
K
94
4941
PISTON SYRINGE
K
94
5485
ABG NEEDLE PROTECTION
K
94
0575
ASPIR-PULSE(TM) SAF-T-VENT
K
93
1873
VACVENT
K
93
0986
BLOOD GAS KIT (NON-STERILE) REORDER NO. 0560
K
92
5453
SHERWOOD MEDICAL ARTERIAL BLOOD GAS KIT I
K
93
0471
SHERWOOD MEDICAL ARTERIAL BLOOD GAS KIT II
K
93
0286
DRI-VENDT/PROVENT/ACCUVENT ARTERIAL BLOOD GAS KITS
K
91
4778
NEOLINE(TM)
K
91
2043
ACCU-VENT(TM) WITH NEEDLE-PRO(TM)
K
90
5464
MEDICAL PROCEDURE KITS/ARTERIAL BLOOD SAMPLING
K
90
2881
LAB-SITE SAFETY NEEDLE
K
90
2632
GAS-LYTE 1CC AND 3CC ARTERIAL BLOOD SAMPLERS
K
90
0302
UMBILICAL CORD BLOOD SAMPLING KIT
K
89
7133
MODEL 1050 - UMBILICAL CORD BLOOD SAMPLING KIT
K
89
5171
BLOOD GAS SAFETY SYRINGE
K
87
5117
CIBA CORNING BALANCED HEPARIN FOR CA++
K
87
2244
CORD-ASSURE UMBILICAL BLOOD GAS KIT
K
87
0720
AIRLIFE ARTERIAL BLOOD GAS SAMPLING SYRINGE
K
84
4615
BIOSAMPLER
K
84
3360
ARTAP ARTERIAL BLOOD SAMPLING DEVICE
K
84
2008
MARQUEST MICRO STIK 9000 SERIES
K
84
1486
ARTERIAL BLOOD SAMPLING KITS
K
84
0986
PREFILLED PULSATOR SYRINGE
K
84
0987
VAPORIZED HEPARIN
K
83
3923
MARZ-175 ARTERIAL BLOOD GAS SYRINGE
K
83
3582
PULSATOR ARTERIAL BLOOD SAMPLING SYRIN
K
83
2545
ARTERIAL BLOOD SAMPLING KIT
K
83
0310
OMNISTICK
K
83
0311
AUTO STIK
K
83
0312
ASPIRATOR
K
83
1034
QUALISTICK ARTERIAL BLOOD SAMPLER
K
83
0333
ABG KITS - CMS 4000 SERIES
K
82
2786
MDM ARTERIAL BLOOD GAS KIT
K
82
2248
DESERET ARTERIAL BLOOD SAMPLING KIT
K
82
1406
ARTERIAL BLOOD SAMPLING KIT
K
82
0875
AUTOSTIK
K
81
2338
PREZA-PAK II, ARTERIAL BLOOD SAMPLING SY
K
81
1860
EASY-FLO ARTERIAL BLOOD GAS KIT
K
81
1199
MARZ-175
K
80
1620
ASPIRATOR
K
80
1435
ORGANON ARTERIAL BLOOD SAMPLER
K
80
1146
SAMPLING KIT
K
80
0860
OMNISTIK, MQ 501GS
K
79
1465
MOSQUITO ARTERIAL BLOOD SAMPLER
K
79
0196
MONOJECT ARTERIAL BLOOD SAMPLING DEVICE
K
78
1857
TRAY, ARTERIAL BLOOD GAS SAMPLING
K
78
1616
OMNI STIK
K
78
0939
BARD-PARKER ARTERIAL MONITORING SYSTEM
K
77
1975
ARTERIAL BLOOD SAMPLING TRAY
K
77
1013
MOSQUITO
CBZ
Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling
CCC
Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling
CCE
Analyzer, Gas, Oxygen, Partial Pressure, Blood-Phase, Indwelling
CCI
Analyzer, Gas, Nitrogen, Gaseous-Phase
CCJ
Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
CCK
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
CCL
Analyzer, Gas, Oxygen, Gaseous-Phase
CCM
Plethysmograph, Pressure
JED
Analyzer, Oxyhemoglobin Concentration, Blood-Phase, Indwelling
JEF
Analyzer, Gas, Neon, Gaseous-Phase
JEG
Analyzer, Gas, Argon, Gaseous-Phase
JEH
Plethysmograph, Volume
JFE
Valve, Switching (Ploss)
KGK
Gas, Collecting Vessel
NHO
Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)
NHP
Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)
NHQ
Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)
OFZ
Blood Specimen Collection Kit (Excludes Hiv Testing)
PNV
Impedance Measuring Device Utilizing Oscillation Techniques
OGK
Orotracheal Intubation Guide Kit
PHZ
Abnormal Breath Sound Device
QEB
Ventilatory Electrical Impedance Tomograph
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
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-b—diagnostic-devices
/
CBT
/
K830333
View Source
ABG KITS - CMS 4000 SERIES
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K830333
510(k) Type
Traditional
Applicant
CURRIE MEDICAL SPECIALTIES, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/31/1983
Days to Decision
58 days