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
K
04
0917
PHILIPS ANESTHESIA GAS MONITOR, MODEL M1026B
2
Cleared 510(K)
K
99
4188
MODIFICATION TO AGILENT TECHNOLOGIES ANESTHESIA GAS MONITOR, MODEL M1026A #CO5
2
Cleared 510(K)
K
96
2648
OHMEDA MODEL 5330 ANESTHETIC AGENT MONITOR
2
Cleared 510(K)
K
93
1439
OHMEDA MODEL 5330 ANESTHETIC MONITOR
2
Cleared 510(K)
K
92
6451
DATASCOPE MULTINEX II
2
Cleared 510(K)
K
92
3433
AS/3 ANAESTHESIA MONITORING SYSTEM AIRWAY MODULE
2
Cleared 510(K)
K
92
3276
CAPNOMAC ULTIMA ANESTHESIA MONITOR
2
Cleared 510(K)
K
92
2876
AS/3 COP MODULE
2
Cleared 510(K)
K
93
0303
DATASCOPE MULTINEX ID PLUS
2
Cleared 510(K)
K
91
4295
ANESTHETIC GAS MONITOR TYPE 1304, MODIFIED
2
Cleared 510(K)
K
91
1644
NGM FRAME
2
Cleared 510(K)
K
91
1647
NGM GAS MODULE
2
Cleared 510(K)
K
90
3104
CAPNOMAC ULTIMA (TM) ANESTHESIA MONITOR
2
Cleared 510(K)
K
90
2021
RASCAL II RESPIRATORY AND ANESTHETIC GAS MONITOR
2
Cleared 510(K)
K
89
2854
ANESTHETIC AGENT MONITOR
2
Cleared 510(K)
K
89
2646
BIOCHEM 8100 ANESTHETIC AGENT MONITOR
2
Cleared 510(K)
K
89
0606
OHMEDA 5330 AGENT MONITOR
2
Cleared 510(K)
K
88
3532
ICOR AGENT MONITOR
2
Cleared 510(K)
K
88
1264
PERMA PURE NAFION TUBE DRYER-MODEL ME
2
Cleared 510(K)
K
86
3248
PB GRAPHICS PRINTER AND PB VIDEO DISPLAY
2
Cleared 510(K)
K
86
1397
OHMEDA 5300 ANESTHETIC AGENT MONITOR
2
Cleared 510(K)
K
86
1474
PB253 TO PB254 IR - SPECTROMETER UPGRADE KIT
2
Cleared 510(K)
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
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
/
CBQ
/
K902021
View Source
RASCAL II RESPIRATORY AND ANESTHETIC GAS MONITOR
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K902021
510(k) Type
Traditional
Applicant
ALBION INSTRUMENTS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/9/1990
Days to Decision
159 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)
K
04
0917
PHILIPS ANESTHESIA GAS MONITOR, MODEL M1026B
K
99
4188
MODIFICATION TO AGILENT TECHNOLOGIES ANESTHESIA GAS MONITOR, MODEL M1026A #CO5
K
96
2648
OHMEDA MODEL 5330 ANESTHETIC AGENT MONITOR
K
93
1439
OHMEDA MODEL 5330 ANESTHETIC MONITOR
K
92
6451
DATASCOPE MULTINEX II
K
92
3433
AS/3 ANAESTHESIA MONITORING SYSTEM AIRWAY MODULE
K
92
3276
CAPNOMAC ULTIMA ANESTHESIA MONITOR
K
92
2876
AS/3 COP MODULE
K
93
0303
DATASCOPE MULTINEX ID PLUS
K
91
4295
ANESTHETIC GAS MONITOR TYPE 1304, MODIFIED
K
91
1644
NGM FRAME
K
91
1647
NGM GAS MODULE
K
90
3104
CAPNOMAC ULTIMA (TM) ANESTHESIA MONITOR
K
90
2021
RASCAL II RESPIRATORY AND ANESTHETIC GAS MONITOR
K
89
2854
ANESTHETIC AGENT MONITOR
K
89
2646
BIOCHEM 8100 ANESTHETIC AGENT MONITOR
K
89
0606
OHMEDA 5330 AGENT MONITOR
K
88
3532
ICOR AGENT MONITOR
K
88
1264
PERMA PURE NAFION TUBE DRYER-MODEL ME
K
86
3248
PB GRAPHICS PRINTER AND PB VIDEO DISPLAY
K
86
1397
OHMEDA 5300 ANESTHETIC AGENT MONITOR
K
86
1474
PB253 TO PB254 IR - SPECTROMETER UPGRADE KIT
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
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
/
CBQ
/
K902021
View Source
RASCAL II RESPIRATORY AND ANESTHETIC GAS MONITOR
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K902021
510(k) Type
Traditional
Applicant
ALBION INSTRUMENTS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/9/1990
Days to Decision
159 days