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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
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
K
23
2516
Sentec Digital Monitoring System (SDMS) tCOM+
2
Cleared 510(K)
K
15
1329
SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet
2
Cleared 510(K)
K
13
1253
PERIFLUX 6000
2
Cleared 510(K)
K
11
0474
PHILIPS INTELLIVUE TCG10
2
Cleared 510(K)
K
10
1690
SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE
2
Cleared 510(K)
K
09
3154
TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM
2
Cleared 510(K)
K
04
3357
TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 5202009
2
Cleared 510(K)
K
04
3003
TCM40 MONITORING SYSTEM
2
Cleared 510(K)
K
04
1548
SENTEC DIGITAL MONITOR MODEL #SDM
2
Cleared 510(K)
K
99
0960
PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040)
2
Cleared 510(K)
K
98
0756
COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE
2
Cleared 510(K)
P
81
0037
KONTRON KOLORMON PLUS BLOODGAS MODULE 7267505
2
PMA Approval
P
81
0037
KONTRON CUTANEOUS PCO2 MONITOR
2
PMA Approval
K
91
3013
TCPO2 9260 MODULE - SYSTEM ATHENA
2
Cleared 510(K)
K
90
5225
HBO CABLE ASSEMBLY, RADIOMETER TC-02
2
Cleared 510(K)
K
90
0333
E5280 COMBINED TRANSCUTANEOUS TCP02/TCPCO2 ELECT.
2
Cleared 510(K)
K
89
1481
SIEMENS SIRECUST TRANSCUTANEOUS CARBON DIOXIDE
2
Cleared 510(K)
K
89
0517
TRANSCUTANEOUS O2/CO2 MONITOR
2
Cleared 510(K)
K
88
3606
MODEL HP 15209A TRANS. COMBINED TCP02/TCPCO2 TRANS
2
Cleared 510(K)
P
83
0008
CUTANIOUS GAS MONITOR
2
PMA Approval
P
81
0022
TCO2M MODEL 818 MONITOR
2
PMA Approval
P
81
0022
TCO2M MODEL 818 MONITOR
2
PMA Approval
P
84
0037
MODEL 515 NEONATAL MONIOTR
2
PMA Approval
P
85
0087
LITTON TRANSCUTANEOUS CO2 SYSTEM
2
PMA Approval
P
81
0022
TCO2M MODEL 818 MONITOR
2
PMA Approval
P
82
0019
LIFESPAN(TM) 100 TCPCO2 MONITOR
2
PMA Approval
P
80
0043
RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO
2
PMA Approval
P
82
0019
LIFESPAN(TM) 100 TCPCO2 MONITOR
2
PMA Approval
P
81
0022
TCO2M MODEL 818 MONITOR
2
PMA Approval
P
82
0019
LIFESPAN(TM) 100 TCPCO2 MONITOR
2
PMA Approval
P
81
0037
KONTRON CUTANEOUS PCO2 MONITOR
2
PMA Approval
P
81
0037
KONTRON CUTANEOUS PCO2 MONITOR
2
PMA Approval
P
81
0022
TCO2M MODEL 818 MONITOR
2
PMA Approval
P
81
0037
KONTRON CUTANEOUS PCO2 MONITOR
2
PMA Approval
P
82
0019
LIFESPAN(TM) MODEL 4110 TCPO2/CO2 MONITORING SYSTE
2
PMA Approval
P
81
0022
TCO2M MODEL 818 MONITOR
2
PMA Approval
P
81
0022
TCO2M MODEL 818 MONITOR
2
PMA Approval
P
80
0043
RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO
2
PMA Approval
P
81
0037
KONTRON CUTANEOUS PCO2 MONITOR
2
PMA Approval
P
83
0008
CUTANIOUS GAS MONITOR
2
PMA Approval
P
81
0022
TCO2M MODEL 818 MONITOR
2
PMA Approval
P
83
0008
CUTANIOUS GAS MONITOR
2
PMA Approval
P
81
0022
TCO2M MODEL 818 MONITOR
2
PMA Approval
P
81
0022
TCO2M MODEL 818 MONITOR
2
PMA Approval
P
81
0022
TCO2M MODEL 818 MONITOR
2
PMA Approval
P
81
0022
TCO2M MODEL 818 MONITOR
2
PMA Approval
P
82
0025
TCPCO2 MONITORING SYSTEM
2
PMA Approval
P
80
0043
RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO
2
PMA Approval
P
82
0019
LIFESPAN(TM) 100 TCPCO2 MONITOR
2
PMA Approval
P
81
0037
KONTRON CUTANEOUS PCO2 MONITOR
2
PMA Approval
P
81
0037
KONTRON CUTANEOUS PCO2 MONITOR
2
PMA Approval
P
81
0022
TCO2M MODEL 818 MONITOR
2
PMA Approval
P
80
0043
RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO
2
PMA Approval
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
/
LKD
/
K905225
View Source
HBO CABLE ASSEMBLY, RADIOMETER TC-02
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K905225
510(k) Type
Traditional
Applicant
SECHRIST
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/10/1991
Days to Decision
141 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
KOI
Stimulator, Nerve, Peripheral, Electric
LKD
Monitor, Carbon-Dioxide, Cutaneous
K
23
2516
Sentec Digital Monitoring System (SDMS) tCOM+
K
15
1329
SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet
K
13
1253
PERIFLUX 6000
K
11
0474
PHILIPS INTELLIVUE TCG10
K
10
1690
SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE
K
09
3154
TCM TOSCA MONITORING SYSTEM, TCM COMBIM MONITORING SYSTEM
K
04
3357
TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 5202009
K
04
3003
TCM40 MONITORING SYSTEM
K
04
1548
SENTEC DIGITAL MONITOR MODEL #SDM
K
99
0960
PERIMED TRANSCUTANEOUS PO2 AND PCO2 MONITOR (PF5040)
K
98
0756
COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE
P
81
0037
KONTRON KOLORMON PLUS BLOODGAS MODULE 7267505
P
81
0037
KONTRON CUTANEOUS PCO2 MONITOR
K
91
3013
TCPO2 9260 MODULE - SYSTEM ATHENA
K
90
5225
HBO CABLE ASSEMBLY, RADIOMETER TC-02
K
90
0333
E5280 COMBINED TRANSCUTANEOUS TCP02/TCPCO2 ELECT.
K
89
1481
SIEMENS SIRECUST TRANSCUTANEOUS CARBON DIOXIDE
K
89
0517
TRANSCUTANEOUS O2/CO2 MONITOR
K
88
3606
MODEL HP 15209A TRANS. COMBINED TCP02/TCPCO2 TRANS
P
83
0008
CUTANIOUS GAS MONITOR
P
81
0022
TCO2M MODEL 818 MONITOR
P
81
0022
TCO2M MODEL 818 MONITOR
P
84
0037
MODEL 515 NEONATAL MONIOTR
P
85
0087
LITTON TRANSCUTANEOUS CO2 SYSTEM
P
81
0022
TCO2M MODEL 818 MONITOR
P
82
0019
LIFESPAN(TM) 100 TCPCO2 MONITOR
P
80
0043
RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO
P
82
0019
LIFESPAN(TM) 100 TCPCO2 MONITOR
P
81
0022
TCO2M MODEL 818 MONITOR
P
82
0019
LIFESPAN(TM) 100 TCPCO2 MONITOR
P
81
0037
KONTRON CUTANEOUS PCO2 MONITOR
P
81
0037
KONTRON CUTANEOUS PCO2 MONITOR
P
81
0022
TCO2M MODEL 818 MONITOR
P
81
0037
KONTRON CUTANEOUS PCO2 MONITOR
P
82
0019
LIFESPAN(TM) MODEL 4110 TCPO2/CO2 MONITORING SYSTE
P
81
0022
TCO2M MODEL 818 MONITOR
P
81
0022
TCO2M MODEL 818 MONITOR
P
80
0043
RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO
P
81
0037
KONTRON CUTANEOUS PCO2 MONITOR
P
83
0008
CUTANIOUS GAS MONITOR
P
81
0022
TCO2M MODEL 818 MONITOR
P
83
0008
CUTANIOUS GAS MONITOR
P
81
0022
TCO2M MODEL 818 MONITOR
P
81
0022
TCO2M MODEL 818 MONITOR
P
81
0022
TCO2M MODEL 818 MONITOR
P
81
0022
TCO2M MODEL 818 MONITOR
P
82
0025
TCPCO2 MONITORING SYSTEM
P
80
0043
RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO
P
82
0019
LIFESPAN(TM) 100 TCPCO2 MONITOR
P
81
0037
KONTRON CUTANEOUS PCO2 MONITOR
P
81
0037
KONTRON CUTANEOUS PCO2 MONITOR
P
81
0022
TCO2M MODEL 818 MONITOR
P
80
0043
RADIOMETER TCM-10 TRANSCUTANEOUS CARBON DIOXIDE MO
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
/
LKD
/
K905225
View Source
HBO CABLE ASSEMBLY, RADIOMETER TC-02
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K905225
510(k) Type
Traditional
Applicant
SECHRIST
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/10/1991
Days to Decision
141 days