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
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
K
22
1734
Maxtec MaxO2 ME+p
2
Cleared 510(K)
K
21
3933
Percent Oxygen Sensors
2
Cleared 510(K)
K
21
3948
OxyMinder
2
Cleared 510(K)
K
17
3807
Accu O2 Oxygen Analyzer
2
Cleared 510(K)
K
15
3659
MaxO2ME
2
Cleared 510(K)
K
12
3195
CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIES
2
Cleared 510(K)
K
12
2290
ENVITEC MYSIGN O OXYGEN MEASURING DEVICE
2
Cleared 510(K)
K
11
2402
ULTRAMAXO2 OXYGEN ANALYER
2
Cleared 510(K)
K
08
2655
ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106
2
Cleared 510(K)
K
07
2469
DIGIFLO CONCENTRATOR ANALYZER
2
Cleared 510(K)
K
06
3096
PRECISION OXYGEN MONITOR
2
Cleared 510(K)
K
06
3488
MAXO2 CU
2
Cleared 510(K)
K
05
3407
OXYGEN ANALYZER, MODELS AII 20000A, AII 2000HC, AII 2000M
2
Cleared 510(K)
K
05
1092
DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE (MODEL FAMILY E-CAIOVX) E-CAIOVX, E-CAIOV, E-CAIO, E-COVX, E-COV, E-CO & ACCESACC
2
Cleared 510(K)
K
04
1773
OXYGEN MEDICELS, CITICELS
2
Cleared 510(K)
K
04
0484
MAXO2+, MODEL A AND AE
2
Cleared 510(K)
K
02
4228
RX300 OXYGEN ANALYZER
2
Cleared 510(K)
K
02
4155
MX 300 OXYGEN MONITOR
2
Cleared 510(K)
K
02
3565
OXICHECK
2
Cleared 510(K)
K
01
0318
PRIMA OXYGEN MONITOR
2
Cleared 510(K)
K
00
2382
'ALL 2000' % OXYGEN ANALYZER
2
Cleared 510(K)
K
01
0382
100 SERIES OXYGEN ANALYZER, MODELS 1000-E AND 1000-I
2
Cleared 510(K)
K
00
2384
M-XX OXYGEN SENSORS
2
Cleared 510(K)
K
00
0700
SENSIDYNE OXYGEN ANALYZER & SENSIDYNE OXYGEN MONITOR
2
Cleared 510(K)
K
00
1095
OXYGEN SENSORS, MODELS CIR, C2R, R13, R15, RI7MED, R22MED, R23, R24MED, R29MED, T1, T2,T4, T7 & UFO130
2
Cleared 510(K)
K
99
0403
TED 200T7 OXYGEN MONITOR
2
Cleared 510(K)
K
99
0457
TED 60T OXYGEN ANALYZER
2
Cleared 510(K)
K
99
1884
SIEMENS FIO2 SENSOR
2
Cleared 510(K)
K
98
4295
INVACARE CHECK O2 PLUS CONCENTRATOR ANALYZER (CHECK O2 PLUS)
2
Cleared 510(K)
K
98
3500
PRO2 CHECK OXYGEN INDICATOR
2
Cleared 510(K)
K
98
2619
HP ANESTHESIA GAS MONITOR (WATERTRAP), MODEL A02
2
Cleared 510(K)
K
97
1084
MODEL 02 OXYGEN ANALYZER
2
Cleared 510(K)
K
97
3545
VACU*MED GOLD EDITION OXYGEN GAS ANALYZER
2
Cleared 510(K)
K
97
2992
CERAMATEC MAXCELL AND CAG GALVANIC OXYGEN SENSORS
2
Cleared 510(K)
K
97
3282
HANDI OXYGEN ANALYZER
2
Cleared 510(K)
K
96
3177
TED 191
2
Cleared 510(K)
K
96
3415
VENTREX OXYGEN SENSOR
2
Cleared 510(K)
K
94
3824
GASEOUS OXYGEN ANALYZER (MODEL S-3A) MODIFICATION
2
Cleared 510(K)
K
96
1644
MINIOX 3000 OXYGEN MONITOR
2
Cleared 510(K)
K
95
1038
OXYCHECK OXYGEN MONITOR
2
Cleared 510(K)
K
95
2736
PERCENT OXYGEN SENSOR
2
Cleared 510(K)
K
95
3351
SEATRONICS FAMILY OF GALVANIC OXYGEN SENSORS
2
Cleared 510(K)
K
94
1793
OXYGEN CONCENTRATION STATUS INDICATOR (O.C.S.I.)
2
Cleared 510(K)
K
94
4120
FI02 SENSING MODULE
2
Cleared 510(K)
K
94
2593
OXYCHEK OXYGEN ANALYZER
2
Cleared 510(K)
K
94
4654
OXYGEN CONCENTRATION INDICATOR
2
Cleared 510(K)
K
93
5364
MINIOX 1000 OXYGEN CONCENTRATION INDICATOR
2
Cleared 510(K)
K
92
2438
PRO2 OXYGEN ANALYZER
2
Cleared 510(K)
K
92
2738
VTI OXYGEN ANALYZER
2
Cleared 510(K)
K
92
0338
COMPANION RETROFIT OXYGEN CONCENTRATION INDICATOR
2
Cleared 510(K)
K
91
3392
OXYGEN SENSING DEVICE, MODIFICATION
2
Cleared 510(K)
K
91
0381
BIOCHEM TEMPERATURE/ FIO2 MODULE
2
Cleared 510(K)
K
91
1344
CERION HAND HELD OXYGEN ANALYZER
2
Cleared 510(K)
K
89
6359
AG-820PA FI02 MODULE
2
Cleared 510(K)
K
89
6427
SPACELABS' MODEL 90514, MULTIGAS ANALYZER
2
Cleared 510(K)
K
89
0058
VASCULAR TECHNOLOGY UNIOX OXYGEN ALARM
2
Cleared 510(K)
K
89
4918
HORIZON 2000 FRACTION OF INSPIRED OXYGEN MON. CAP.
2
Cleared 510(K)
K
89
1674
NEONATAL ENVIRONMENTAL MONITOR, MODEL 275
2
Cleared 510(K)
K
89
0144
OXITRON OXYGEN SENSOR
2
Cleared 510(K)
K
89
0958
OXITRON OXYGEN ANALYZER
2
Cleared 510(K)
K
88
2352
MODEL IDS640 PATIENT DATA DISPLAY & STORAGE MONIT.
2
Cleared 510(K)
K
88
0378
LOTA, LIFECARE OXYGEN/TEMPERATURE ANALYZER 36-001
2
Cleared 510(K)
K
88
3254
MULTINEX MONITOR (MODIFICATION)
2
Cleared 510(K)
K
88
2743
OHMEDA 5250 RGM (RESPIRATORY GAS MONITOR)
2
Cleared 510(K)
K
88
1663
OXYGEN/TEMPERATURE ANALYZER MODEL 300 SERIES
2
Cleared 510(K)
K
88
1473
SL01 OXYGEN ANALYZER
2
Cleared 510(K)
K
88
1472
SL02 OXYGEN ANALYZER
2
Cleared 510(K)
K
87
5183
LC OXYGEN ANALYZER
2
Cleared 510(K)
K
88
0448
CERION OXY THRESHOLD ALARM
2
Cleared 510(K)
K
87
3068
OXYGEN ANALYZER MODEL 800 SERIES
2
Cleared 510(K)
K
87
2001
MODEL TPC-1A OXYGEN ANALYZER
2
Cleared 510(K)
K
87
1337
M-2 OXYGEN/TEMPERATURE MONITOR
2
Cleared 510(K)
K
86
3158
MODEL T-1 OXYGEN ANALYZER
2
Cleared 510(K)
K
86
3806
MODEL A-1 OXYGEN ANALYZER
2
Cleared 510(K)
K
86
2113
NO. 100352 GALVANIC OXYGEN SENSOR
2
Cleared 510(K)
K
86
1625
SERVO GAS MONITOR 120
2
Cleared 510(K)
K
85
4799
EMERSON MODEL 3MV-OAA ALARM MODULE
2
Cleared 510(K)
K
85
4599
VICKERS MEDICAL MODEL 273 OXYGEN MONITOR
2
Cleared 510(K)
K
85
2823
DMA OXYGEN MONITOR
2
Cleared 510(K)
K
85
3082
OHMEDA 5120 OXYGEN MONITOR
2
Cleared 510(K)
K
85
2275
VASCULAR TECH # 100123 POLAROGRAPHIC OXGYEN SENSOR
2
Cleared 510(K)
K
84
3847
O2 TEST
2
Cleared 510(K)
K
84
0645
ENGSTROM ELIZA DUO CO2 & O2 ANALYZ
2
Cleared 510(K)
K
84
0565
MONITOR 5590- ANALYZER 5595EC
2
Cleared 510(K)
K
84
0392
NOVOX OXYGEN ANALYZER 400
2
Cleared 510(K)
K
84
0361
OXYGEN ANALYZER 200
2
Cleared 510(K)
K
83
3496
OXYGEN MONITOR/CONTROLLER
2
Cleared 510(K)
K
83
3995
MINI OX II
2
Cleared 510(K)
K
83
1522
BIO-TEK PERCENT OXYGEN MONITOR 74222
2
Cleared 510(K)
K
83
1238
OXYMED
2
Cleared 510(K)
K
83
0446
OXYGEN MONITOR OHIO 5100
2
Cleared 510(K)
K
83
0124
OPTION A02 MODEL 15202A
2
Cleared 510(K)
K
82
3449
RESPIRATORY GAS ANALYZER
2
Cleared 510(K)
K
82
3374
OXYGEN MONITOR IL 408
2
Cleared 510(K)
K
82
3232
YSI #2650 SINGLE-DISPLAY OXYGEN & TEMP
2
Cleared 510(K)
K
82
3231
YSI #2600 MULTI-CHANNEL DUAL-DISPLAY
2
Cleared 510(K)
K
82
2608
MK 808 SERIES NASAL OXYGEN SAMPLER
2
Cleared 510(K)
K
82
1392
MODEL TPC-1 OXYGEN ANALYZER
2
Cleared 510(K)
K
81
3198
RESPIRATOR MONITOR
2
Cleared 510(K)
K
81
2854
VENTRONICS #5590 ECII OXYGEN MONITOR
2
Cleared 510(K)
K
81
2855
VENTRONICS #5595 ECII OXYGEN ANALYZER
2
Cleared 510(K)
K
81
2587
MONO 2 OXYGEN MONITOR
2
Cleared 510(K)
K
81
2040
OXYGEN MONITOR 140/141
2
Cleared 510(K)
K
81
1702
MODEL 381 HOME OXYGEN SENTRY
2
Cleared 510(K)
K
81
0571
NEOCARE OXYGEN MONITOR
2
Cleared 510(K)
K
80
2762
NORMOCAP CR-102, RECORDER UNIT
2
Cleared 510(K)
K
80
1607
MOM 2
2
Cleared 510(K)
K
80
1083
NORMCAP CD-102, CARBON DIOXIDE ANALYZER
2
Cleared 510(K)
K
79
2356
OXEQUIP MODEL 34 MED*STAR OXYGEN MONITOR
2
Cleared 510(K)
K
79
1199
ANESTHESIA OXYGEN ANALYZER MODEL 101
2
Cleared 510(K)
K
79
0785
MODEL M25RL, (CRC) OXYGEN ANALYZER
2
Cleared 510(K)
K
79
0784
MODEL M25R, OXYGEN ANALYZER
2
Cleared 510(K)
K
78
2062
ANALYZER, OXYGEN MODEL M25RA & M25RAD
2
Cleared 510(K)
K
78
2114
MONITOR, OXYCHEK OXYGEN
2
Cleared 510(K)
K
78
1209
MONITOR, OXYGEN, MODEL 3000A
2
Cleared 510(K)
K
78
0448
TRANSPORTABLE OXYGEN PURITY ANALYZER
2
Cleared 510(K)
K
77
1028
ANALYZER, OXYGEN, MODEL OM-92
2
Cleared 510(K)
K
77
0207
MONITOR, OXYGEN, MODEL 78216C
2
Cleared 510(K)
K
76
0338
MONITOR, RESP. OXYGEN (TOP)
2
Cleared 510(K)
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 30 November 2024 at 11:09 am
AN
/
subpart-b—diagnostic-devices
/
CCL
/
K024228
View Source
RX300 OXYGEN ANALYZER
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K024228
510(k) Type
Traditional
Applicant
TELEDYNE ANALYTICAL INSTRUMENTS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/17/2003
Days to Decision
206 days
Submission Type
Statement
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
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
K
22
1734
Maxtec MaxO2 ME+p
K
21
3933
Percent Oxygen Sensors
K
21
3948
OxyMinder
K
17
3807
Accu O2 Oxygen Analyzer
K
15
3659
MaxO2ME
K
12
3195
CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIES
K
12
2290
ENVITEC MYSIGN O OXYGEN MEASURING DEVICE
K
11
2402
ULTRAMAXO2 OXYGEN ANALYER
K
08
2655
ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106
K
07
2469
DIGIFLO CONCENTRATOR ANALYZER
K
06
3096
PRECISION OXYGEN MONITOR
K
06
3488
MAXO2 CU
K
05
3407
OXYGEN ANALYZER, MODELS AII 20000A, AII 2000HC, AII 2000M
K
05
1092
DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE (MODEL FAMILY E-CAIOVX) E-CAIOVX, E-CAIOV, E-CAIO, E-COVX, E-COV, E-CO & ACCESACC
K
04
1773
OXYGEN MEDICELS, CITICELS
K
04
0484
MAXO2+, MODEL A AND AE
K
02
4228
RX300 OXYGEN ANALYZER
K
02
4155
MX 300 OXYGEN MONITOR
K
02
3565
OXICHECK
K
01
0318
PRIMA OXYGEN MONITOR
K
00
2382
'ALL 2000' % OXYGEN ANALYZER
K
01
0382
100 SERIES OXYGEN ANALYZER, MODELS 1000-E AND 1000-I
K
00
2384
M-XX OXYGEN SENSORS
K
00
0700
SENSIDYNE OXYGEN ANALYZER & SENSIDYNE OXYGEN MONITOR
K
00
1095
OXYGEN SENSORS, MODELS CIR, C2R, R13, R15, RI7MED, R22MED, R23, R24MED, R29MED, T1, T2,T4, T7 & UFO130
K
99
0403
TED 200T7 OXYGEN MONITOR
K
99
0457
TED 60T OXYGEN ANALYZER
K
99
1884
SIEMENS FIO2 SENSOR
K
98
4295
INVACARE CHECK O2 PLUS CONCENTRATOR ANALYZER (CHECK O2 PLUS)
K
98
3500
PRO2 CHECK OXYGEN INDICATOR
K
98
2619
HP ANESTHESIA GAS MONITOR (WATERTRAP), MODEL A02
K
97
1084
MODEL 02 OXYGEN ANALYZER
K
97
3545
VACU*MED GOLD EDITION OXYGEN GAS ANALYZER
K
97
2992
CERAMATEC MAXCELL AND CAG GALVANIC OXYGEN SENSORS
K
97
3282
HANDI OXYGEN ANALYZER
K
96
3177
TED 191
K
96
3415
VENTREX OXYGEN SENSOR
K
94
3824
GASEOUS OXYGEN ANALYZER (MODEL S-3A) MODIFICATION
K
96
1644
MINIOX 3000 OXYGEN MONITOR
K
95
1038
OXYCHECK OXYGEN MONITOR
K
95
2736
PERCENT OXYGEN SENSOR
K
95
3351
SEATRONICS FAMILY OF GALVANIC OXYGEN SENSORS
K
94
1793
OXYGEN CONCENTRATION STATUS INDICATOR (O.C.S.I.)
K
94
4120
FI02 SENSING MODULE
K
94
2593
OXYCHEK OXYGEN ANALYZER
K
94
4654
OXYGEN CONCENTRATION INDICATOR
K
93
5364
MINIOX 1000 OXYGEN CONCENTRATION INDICATOR
K
92
2438
PRO2 OXYGEN ANALYZER
K
92
2738
VTI OXYGEN ANALYZER
K
92
0338
COMPANION RETROFIT OXYGEN CONCENTRATION INDICATOR
K
91
3392
OXYGEN SENSING DEVICE, MODIFICATION
K
91
0381
BIOCHEM TEMPERATURE/ FIO2 MODULE
K
91
1344
CERION HAND HELD OXYGEN ANALYZER
K
89
6359
AG-820PA FI02 MODULE
K
89
6427
SPACELABS' MODEL 90514, MULTIGAS ANALYZER
K
89
0058
VASCULAR TECHNOLOGY UNIOX OXYGEN ALARM
K
89
4918
HORIZON 2000 FRACTION OF INSPIRED OXYGEN MON. CAP.
K
89
1674
NEONATAL ENVIRONMENTAL MONITOR, MODEL 275
K
89
0144
OXITRON OXYGEN SENSOR
K
89
0958
OXITRON OXYGEN ANALYZER
K
88
2352
MODEL IDS640 PATIENT DATA DISPLAY & STORAGE MONIT.
K
88
0378
LOTA, LIFECARE OXYGEN/TEMPERATURE ANALYZER 36-001
K
88
3254
MULTINEX MONITOR (MODIFICATION)
K
88
2743
OHMEDA 5250 RGM (RESPIRATORY GAS MONITOR)
K
88
1663
OXYGEN/TEMPERATURE ANALYZER MODEL 300 SERIES
K
88
1473
SL01 OXYGEN ANALYZER
K
88
1472
SL02 OXYGEN ANALYZER
K
87
5183
LC OXYGEN ANALYZER
K
88
0448
CERION OXY THRESHOLD ALARM
K
87
3068
OXYGEN ANALYZER MODEL 800 SERIES
K
87
2001
MODEL TPC-1A OXYGEN ANALYZER
K
87
1337
M-2 OXYGEN/TEMPERATURE MONITOR
K
86
3158
MODEL T-1 OXYGEN ANALYZER
K
86
3806
MODEL A-1 OXYGEN ANALYZER
K
86
2113
NO. 100352 GALVANIC OXYGEN SENSOR
K
86
1625
SERVO GAS MONITOR 120
K
85
4799
EMERSON MODEL 3MV-OAA ALARM MODULE
K
85
4599
VICKERS MEDICAL MODEL 273 OXYGEN MONITOR
K
85
2823
DMA OXYGEN MONITOR
K
85
3082
OHMEDA 5120 OXYGEN MONITOR
K
85
2275
VASCULAR TECH # 100123 POLAROGRAPHIC OXGYEN SENSOR
K
84
3847
O2 TEST
K
84
0645
ENGSTROM ELIZA DUO CO2 & O2 ANALYZ
K
84
0565
MONITOR 5590- ANALYZER 5595EC
K
84
0392
NOVOX OXYGEN ANALYZER 400
K
84
0361
OXYGEN ANALYZER 200
K
83
3496
OXYGEN MONITOR/CONTROLLER
K
83
3995
MINI OX II
K
83
1522
BIO-TEK PERCENT OXYGEN MONITOR 74222
K
83
1238
OXYMED
K
83
0446
OXYGEN MONITOR OHIO 5100
K
83
0124
OPTION A02 MODEL 15202A
K
82
3449
RESPIRATORY GAS ANALYZER
K
82
3374
OXYGEN MONITOR IL 408
K
82
3232
YSI #2650 SINGLE-DISPLAY OXYGEN & TEMP
K
82
3231
YSI #2600 MULTI-CHANNEL DUAL-DISPLAY
K
82
2608
MK 808 SERIES NASAL OXYGEN SAMPLER
K
82
1392
MODEL TPC-1 OXYGEN ANALYZER
K
81
3198
RESPIRATOR MONITOR
K
81
2854
VENTRONICS #5590 ECII OXYGEN MONITOR
K
81
2855
VENTRONICS #5595 ECII OXYGEN ANALYZER
K
81
2587
MONO 2 OXYGEN MONITOR
K
81
2040
OXYGEN MONITOR 140/141
K
81
1702
MODEL 381 HOME OXYGEN SENTRY
K
81
0571
NEOCARE OXYGEN MONITOR
K
80
2762
NORMOCAP CR-102, RECORDER UNIT
K
80
1607
MOM 2
K
80
1083
NORMCAP CD-102, CARBON DIOXIDE ANALYZER
K
79
2356
OXEQUIP MODEL 34 MED*STAR OXYGEN MONITOR
K
79
1199
ANESTHESIA OXYGEN ANALYZER MODEL 101
K
79
0785
MODEL M25RL, (CRC) OXYGEN ANALYZER
K
79
0784
MODEL M25R, OXYGEN ANALYZER
K
78
2062
ANALYZER, OXYGEN MODEL M25RA & M25RAD
K
78
2114
MONITOR, OXYCHEK OXYGEN
K
78
1209
MONITOR, OXYGEN, MODEL 3000A
K
78
0448
TRANSPORTABLE OXYGEN PURITY ANALYZER
K
77
1028
ANALYZER, OXYGEN, MODEL OM-92
K
77
0207
MONITOR, OXYGEN, MODEL 78216C
K
76
0338
MONITOR, RESP. OXYGEN (TOP)
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
/
CCL
/
K024228
View Source
RX300 OXYGEN ANALYZER
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K024228
510(k) Type
Traditional
Applicant
TELEDYNE ANALYTICAL INSTRUMENTS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/17/2003
Days to Decision
206 days
Submission Type
Statement