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
K
93
5778
VIA 1-01 INFUSION PUMP/BLOOD CHEMISTRY SYSTEM
2
Cleared 510(K)
K
91
2145
SYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIA
2
Cleared 510(K)
K
91
0453
TOPS NEEDLE TIP PROBE & PVC TIP PROBE
2
Cleared 510(K)
K
90
5397
PB3200 INTRA-ARTERIAL BLOOD GAS MONITORING SYSTEM
2
Cleared 510(K)
K
89
6311
OPTEX BLOOD GAS MONITORING SYSTEM
2
Cleared 510(K)
K
89
0624
TISSUE OXYGEN MONITOR SYSTEM, MODEL II
2
Cleared 510(K)
K
89
5150
CONTINUCATH 1000 INTRAVASCULAR OXYGEN MONITORING
2
Cleared 510(K)
K
89
5149
NEOCATH 1000 UMBILICAL ARTERY OXYGEN MONITORING SY
2
Cleared 510(K)
K
88
4063
BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR SYSTEM
2
Cleared 510(K)
K
87
5225
UMBILICAL ARTERY OXYGEN SENSOR
2
Cleared 510(K)
K
87
2896
UMBILICAL ARTERY OXYGEN PROBE MODEL UAP-100
2
Cleared 510(K)
K
87
2125
BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR. SYSTEM
2
Cleared 510(K)
K
86
0808
CONTINUCATH
2
Cleared 510(K)
K
86
0106
OXYGEN MONITOR NO. OM-100, OXYGEN PROBE NO. OP-100
2
Cleared 510(K)
K
85
3786
OXYGEN MONITOR OM-100 & OXYGEN PROBE OP-100
2
Cleared 510(K)
K
84
3912
INTRAVASCULAR BLOOD GAS SYSTEM
2
Cleared 510(K)
K
84
0102
ARTERIAL BLOOD GAS INTERPRETATION PROG
2
Cleared 510(K)
K
83
2793
NEOCATH 1000 W/HEPCOTE
2
Cleared 510(K)
K
81
1071
VENOUS OXYGEN PROBE
2
Cleared 510(K)
K
78
1271
MONITOR, PO2, INTRAVASCULAR
2
Cleared 510(K)
K
78
0850
SEARLE NEONATAL OXYGEN PROBE
2
Cleared 510(K)
K
77
1116
CATHETER, PO2, INTRAVASUCLAR, CITADEL
2
Cleared 510(K)
K
76
0350
MONITOR, CITADEL INTRAVASCULAR PO2
2
Cleared 510(K)
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 6 December 2024 at 11:05 pm
AN
/
subpart-b—diagnostic-devices
/
CCE
/
K780850
View Source
SEARLE NEONATAL OXYGEN PROBE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K780850
510(k) Type
Traditional
Applicant
WILL ROSS CO.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/23/1978
Days to Decision
93 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
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
K
93
5778
VIA 1-01 INFUSION PUMP/BLOOD CHEMISTRY SYSTEM
K
91
2145
SYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIA
K
91
0453
TOPS NEEDLE TIP PROBE & PVC TIP PROBE
K
90
5397
PB3200 INTRA-ARTERIAL BLOOD GAS MONITORING SYSTEM
K
89
6311
OPTEX BLOOD GAS MONITORING SYSTEM
K
89
0624
TISSUE OXYGEN MONITOR SYSTEM, MODEL II
K
89
5150
CONTINUCATH 1000 INTRAVASCULAR OXYGEN MONITORING
K
89
5149
NEOCATH 1000 UMBILICAL ARTERY OXYGEN MONITORING SY
K
88
4063
BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR SYSTEM
K
87
5225
UMBILICAL ARTERY OXYGEN SENSOR
K
87
2896
UMBILICAL ARTERY OXYGEN PROBE MODEL UAP-100
K
87
2125
BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR. SYSTEM
K
86
0808
CONTINUCATH
K
86
0106
OXYGEN MONITOR NO. OM-100, OXYGEN PROBE NO. OP-100
K
85
3786
OXYGEN MONITOR OM-100 & OXYGEN PROBE OP-100
K
84
3912
INTRAVASCULAR BLOOD GAS SYSTEM
K
84
0102
ARTERIAL BLOOD GAS INTERPRETATION PROG
K
83
2793
NEOCATH 1000 W/HEPCOTE
K
81
1071
VENOUS OXYGEN PROBE
K
78
1271
MONITOR, PO2, INTRAVASCULAR
K
78
0850
SEARLE NEONATAL OXYGEN PROBE
K
77
1116
CATHETER, PO2, INTRAVASUCLAR, CITADEL
K
76
0350
MONITOR, CITADEL INTRAVASCULAR PO2
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
/
CCE
/
K780850
View Source
SEARLE NEONATAL OXYGEN PROBE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K780850
510(k) Type
Traditional
Applicant
WILL ROSS CO.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/23/1978
Days to Decision
93 days