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
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
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
K
00
3943
MICROGAS 7650 TRANSCUTANEOUS MONITOR
2
Cleared 510(K)
K
99
1644
MICROGAS 7650 TRANSCUTANEOUS MONITOR
2
Cleared 510(K)
K
98
0287
SIEMENS SC9000/SC9015 TCP02/C02 MODULE
2
Cleared 510(K)
K
92
4709
SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE
2
Cleared 510(K)
K
92
4679
OXYCARE(TM) OXYGEN CONTROLLER/MONITOR
2
Cleared 510(K)
K
92
5910
HEWLETT-PACKARD MODEL M1018A TCPO2/TOPCO2 MODULE
2
Cleared 510(K)
K
89
3133
HORIZON 2110/HORIZON 2210 264-XXX-XXX/261-XXX-XXX
2
Cleared 510(K)
K
87
0805
MODEL 840 TRANSCUTAN. OXYGEN/CARBON DIOX. MONITOR
2
Cleared 510(K)
K
86
1861
515A NEO-TRAK NEONATAL MONITOR
2
Cleared 510(K)
K
86
0124
HORIZON 2000 TRANSCUTANEOUS GAS MONITORING
2
Cleared 510(K)
K
86
0951
KONTRON CUTANEOUS PO2 MONITOR 820
2
Cleared 510(K)
K
85
2959
PO-510 TCPO2 MONITOR
2
Cleared 510(K)
K
85
1451
STAT GAS MODULE
2
Cleared 510(K)
K
84
4253
NOVAMETRIX 811 TRANSCO2M PORTABLE TRANSCUTANEOUS 2
2
Cleared 510(K)
K
84
4079
NOVAMETRIX 860 PROTA. TRANSCUTANEOUS OXYGEN
2
Cleared 510(K)
K
84
2497
SERVOMED OXYMONITO SMK 363
2
Cleared 510(K)
K
84
2374
NOVAMETRIX 850 TRANSCUTANEOUS OXYGEN
2
Cleared 510(K)
K
84
0993
TRANSCUTANEOUS 800-OXYGEN MONITORS/801
2
Cleared 510(K)
K
84
0918
MICRO SPAN TRANSCUTANEOUS OXYGEN MONIT
2
Cleared 510(K)
K
84
0919
DAYPAK SYS VII CATHETER CARE KIT
2
Cleared 510(K)
K
83
1319
PATIENT MONITOR #404
2
Cleared 510(K)
K
83
4057
IL 301 PORTABLE TRANSCUT. OXYGEN MONI
2
Cleared 510(K)
K
83
2652
OXY MONITOR 5-RANGE DUAL-THERMISTOR
2
Cleared 510(K)
K
83
0197
TRANSCUTANEOUS BLOOD OXYGEN SENSOR SYS
2
Cleared 510(K)
K
83
1744
TRANSCUTANEOUS OXYGEN MONITOR OPTION
2
Cleared 510(K)
K
83
1460
AS 30/TCP MODULE
2
Cleared 510(K)
K
82
2328
IL 301 TRANSCUTANEOUS OXYGEN MONITOR
2
Cleared 510(K)
K
82
1936
CRITIKON OXYGEN MONITOR, MODEL 8030
2
Cleared 510(K)
K
81
3350
NOVAMETRIX MODEL 807 TRANSCUT. MONITOR
2
Cleared 510(K)
K
81
3347
CRITIKON TRANSCUTANEOUS GAS MONITORS
2
Cleared 510(K)
K
81
3352
NOVAMETRIX MODEL 816A TRANSCUT. OXYGEN
2
Cleared 510(K)
K
81
3351
NOVAMETRIX NAVAGRAPH MODEL 312 RECORDER
2
Cleared 510(K)
K
81
2167
MODEL 78850 OXYGEN MONITOR
2
Cleared 510(K)
K
81
1836
PO-200 BLOOD OXYGEN MONITOR
2
Cleared 510(K)
K
81
0999
CORDIS TCPO2 TRANCUTANEOUS OXYGEN PRESS
2
Cleared 510(K)
K
81
1470
LIFESPAN 100
2
Cleared 510(K)
K
80
2978
TRANSCUTANEOUS BLOOD OXYGEN MONITOR #300
2
Cleared 510(K)
K
80
2846
TCM202 TCPO2 & TCM204 TCPO2/PO2 REC. SY.
2
Cleared 510(K)
K
80
0988
NOVAMETRIX TCOMETTE #809 TRANS. MONITOR
2
Cleared 510(K)
K
80
0631
OXYMETER
2
Cleared 510(K)
K
79
1559
ROCHE SENSOR ADAPTOR
2
Cleared 510(K)
K
79
2011
TC02M PRECISION GAS CALIBRATOR
2
Cleared 510(K)
K
79
2010
TC02M ELECTRODE ADHESIVE RINGS
2
Cleared 510(K)
K
79
2009
TC02 M OXYGEN ELECTRODE CONTACT
2
Cleared 510(K)
K
79
1152
TCO2M MODEL 818
2
Cleared 510(K)
K
78
1910
MONITOR, SENSOMATIII OXYGEN
2
Cleared 510(K)
K
78
0458
TRANSCUTANEOUS OXYGEN PERFUSION MONITOR
2
Cleared 510(K)
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 30 November 2024 at 11:09 am
AN
/
subpart-c—monitoring-devices
/
KLK
/
K844253
View Source
NOVAMETRIX 811 TRANSCO2M PORTABLE TRANSCUTANEOUS 2
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K844253
510(k) Type
Traditional
Applicant
NOVAMETRIX MEDICAL SYSTEMS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/10/1985
Days to Decision
69 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
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
K
00
3943
MICROGAS 7650 TRANSCUTANEOUS MONITOR
K
99
1644
MICROGAS 7650 TRANSCUTANEOUS MONITOR
K
98
0287
SIEMENS SC9000/SC9015 TCP02/C02 MODULE
K
92
4709
SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE
K
92
4679
OXYCARE(TM) OXYGEN CONTROLLER/MONITOR
K
92
5910
HEWLETT-PACKARD MODEL M1018A TCPO2/TOPCO2 MODULE
K
89
3133
HORIZON 2110/HORIZON 2210 264-XXX-XXX/261-XXX-XXX
K
87
0805
MODEL 840 TRANSCUTAN. OXYGEN/CARBON DIOX. MONITOR
K
86
1861
515A NEO-TRAK NEONATAL MONITOR
K
86
0124
HORIZON 2000 TRANSCUTANEOUS GAS MONITORING
K
86
0951
KONTRON CUTANEOUS PO2 MONITOR 820
K
85
2959
PO-510 TCPO2 MONITOR
K
85
1451
STAT GAS MODULE
K
84
4253
NOVAMETRIX 811 TRANSCO2M PORTABLE TRANSCUTANEOUS 2
K
84
4079
NOVAMETRIX 860 PROTA. TRANSCUTANEOUS OXYGEN
K
84
2497
SERVOMED OXYMONITO SMK 363
K
84
2374
NOVAMETRIX 850 TRANSCUTANEOUS OXYGEN
K
84
0993
TRANSCUTANEOUS 800-OXYGEN MONITORS/801
K
84
0918
MICRO SPAN TRANSCUTANEOUS OXYGEN MONIT
K
84
0919
DAYPAK SYS VII CATHETER CARE KIT
K
83
1319
PATIENT MONITOR #404
K
83
4057
IL 301 PORTABLE TRANSCUT. OXYGEN MONI
K
83
2652
OXY MONITOR 5-RANGE DUAL-THERMISTOR
K
83
0197
TRANSCUTANEOUS BLOOD OXYGEN SENSOR SYS
K
83
1744
TRANSCUTANEOUS OXYGEN MONITOR OPTION
K
83
1460
AS 30/TCP MODULE
K
82
2328
IL 301 TRANSCUTANEOUS OXYGEN MONITOR
K
82
1936
CRITIKON OXYGEN MONITOR, MODEL 8030
K
81
3350
NOVAMETRIX MODEL 807 TRANSCUT. MONITOR
K
81
3347
CRITIKON TRANSCUTANEOUS GAS MONITORS
K
81
3352
NOVAMETRIX MODEL 816A TRANSCUT. OXYGEN
K
81
3351
NOVAMETRIX NAVAGRAPH MODEL 312 RECORDER
K
81
2167
MODEL 78850 OXYGEN MONITOR
K
81
1836
PO-200 BLOOD OXYGEN MONITOR
K
81
0999
CORDIS TCPO2 TRANCUTANEOUS OXYGEN PRESS
K
81
1470
LIFESPAN 100
K
80
2978
TRANSCUTANEOUS BLOOD OXYGEN MONITOR #300
K
80
2846
TCM202 TCPO2 & TCM204 TCPO2/PO2 REC. SY.
K
80
0988
NOVAMETRIX TCOMETTE #809 TRANS. MONITOR
K
80
0631
OXYMETER
K
79
1559
ROCHE SENSOR ADAPTOR
K
79
2011
TC02M PRECISION GAS CALIBRATOR
K
79
2010
TC02M ELECTRODE ADHESIVE RINGS
K
79
2009
TC02 M OXYGEN ELECTRODE CONTACT
K
79
1152
TCO2M MODEL 818
K
78
1910
MONITOR, SENSOMATIII OXYGEN
K
78
0458
TRANSCUTANEOUS OXYGEN PERFUSION MONITOR
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
/
KLK
/
K844253
View Source
NOVAMETRIX 811 TRANSCO2M PORTABLE TRANSCUTANEOUS 2
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K844253
510(k) Type
Traditional
Applicant
NOVAMETRIX MEDICAL SYSTEMS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/10/1985
Days to Decision
69 days