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
K
19
2584
BEACON Caresystem Model 00002144
2
Cleared 510(K)
K
19
2595
ExSpiron 2Xi
2
Cleared 510(K)
K
18
0788
Gas Module 3
2
Cleared 510(K)
K
17
3181
ExSpiron 1Xi
2
Cleared 510(K)
K
16
2131
ExSpiron 1Xi
2
Cleared 510(K)
K
13
0170
EXSPIRON 1XI
2
Cleared 510(K)
K
12
0087
EXSPIRON
2
Cleared 510(K)
K
10
3578
PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST
2
Cleared 510(K)
K
09
1853
WRIGHT RESPIROMETER, MARK 8, AND 14 RESPIROMETER, MODEL 700-021, 700-008, 700-014
2
Cleared 510(K)
K
09
2217
MERCURY VCO2
2
Cleared 510(K)
K
09
1459
PHILIPS NM3 MONITOR, MODEL 7900
2
Cleared 510(K)
K
08
0652
MERCURY VCO2 MODULE WITH CAPNOSTAT 5
2
Cleared 510(K)
K
06
2754
GAS MODULE SE, MODEL 0998-00-0481-02
2
Cleared 510(K)
K
05
1279
CALDYNE, INC. EXHALOMETER EX100, MODEL EX100
2
Cleared 510(K)
K
98
3274
STARTRACK INFANT GRAPHICS MONITOR
2
Cleared 510(K)
K
97
2086
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS311
2
Cleared 510(K)
K
93
2098
CAPNOMAC ULTIMA ANESTHESIA MONITOR
2
Cleared 510(K)
K
93
1542
NEWPORT COMPASS EXHALED TIDAL VOLUME MONITOR
2
Cleared 510(K)
K
92
1717
BICORE SMARTVALVE OCCLUSION VALVE
2
Cleared 510(K)
K
90
3674
MODEL 295 ELECTRONIC RESPIROMETER
2
Cleared 510(K)
K
90
3959
NEONATAL METASCOPE
2
Cleared 510(K)
K
90
1885
PARTNER VOLUME MONITOR
2
Cleared 510(K)
K
89
0932
CAV 3.0C SOFTWARE PROGRAM
2
Cleared 510(K)
K
88
4910
MODEL 1010, CY-MET
2
Cleared 510(K)
K
88
4959
RESPITRAK
2
Cleared 510(K)
K
88
4942
MONAGHAN RVM, MODEL 761
2
Cleared 510(K)
K
89
0724
MOFIFICATION BEAR NVM-1 NEONATAL VOLUME MONITOR
2
Cleared 510(K)
K
87
2660
BEAR NVM-1
2
Cleared 510(K)
K
86
4886
RESPIGRAPH-RESPISOMNOGRAPH-RESPICENTRAL
2
Cleared 510(K)
K
86
3866
RESPIRADYNE II(TM)
2
Cleared 510(K)
K
86
3538
RESPICENTRAL(TM)
2
Cleared 510(K)
K
86
2687
OHMEDA 5410 VOLUME MONITOR
2
Cleared 510(K)
K
86
2688
OHMEDA 5420 VOLUME MONITOR
2
Cleared 510(K)
K
85
4956
RESPIGRAPH
2
Cleared 510(K)
K
85
3346
BEAR NICU-1
2
Cleared 510(K)
K
85
2692
RESPITRACE 300SC
2
Cleared 510(K)
K
84
3799
OHMEDA RM311 RESPIROMETER
2
Cleared 510(K)
K
84
3800
OHMEDA RM121 RESPIROMETER
2
Cleared 510(K)
K
84
0975
RICO RESPIRATION MONITOR
2
Cleared 510(K)
K
84
0453
MEDISHIELD PVM RESPIROMETER
2
Cleared 510(K)
K
82
3780
RESPITRACE 300SC
2
Cleared 510(K)
K
82
3783
RESPICOMB
2
Cleared 510(K)
K
83
2565
OHIO 5400 VOLUME MONITOR
2
Cleared 510(K)
K
82
2689
PORTABLE MONITORING & SCREENING SPIROM.
2
Cleared 510(K)
K
83
1237
SPIROMED RESPIROMETER
2
Cleared 510(K)
K
83
0995
POCKET SPIROMETER
2
Cleared 510(K)
K
82
3782
RESPITRACE SYSTEM
2
Cleared 510(K)
K
82
3922
COMPUTERIZED SPIROMETRY SYSTEM
2
Cleared 510(K)
K
82
3555
MAGTARAK RESPIRATORY MONITOR & FLOW SENS
2
Cleared 510(K)
K
82
2912
BEAR VM-90 VENTILATION MONITOR
2
Cleared 510(K)
K
81
2956
SPIROX H
2
Cleared 510(K)
K
81
2959
SPIROX A
2
Cleared 510(K)
K
81
2046
TIDAL VOLUME MONITOR 150
2
Cleared 510(K)
K
80
0086
RMS 111F RESPIRATORY MONITORING SYSTEM
2
Cleared 510(K)
K
79
2573
ALARM USED W/MONITORING SPIROMETER
2
Cleared 510(K)
K
79
2572
EMPIRE SPIROMETER
2
Cleared 510(K)
K
78
2145
SPIROMETER, MINI POSITIVE
2
Cleared 510(K)
K
78
0064
SPIROMETER, MONITORING W/ALARM
2
Cleared 510(K)
K
77
2016
RESPITRACE
2
Cleared 510(K)
K
77
0907
SPIROMETEO EXHAUST
2
Cleared 510(K)
K
76
0971
POSITIVE DISPLACEMENT SPIROMETER
2
Cleared 510(K)
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
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
/
BZK
/
K843799
View Source
OHMEDA RM311 RESPIROMETER
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K843799
510(k) Type
Traditional
Applicant
OHMEDA MEDICAL
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/4/1984
Days to Decision
7 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)
K
19
2584
BEACON Caresystem Model 00002144
K
19
2595
ExSpiron 2Xi
K
18
0788
Gas Module 3
K
17
3181
ExSpiron 1Xi
K
16
2131
ExSpiron 1Xi
K
13
0170
EXSPIRON 1XI
K
12
0087
EXSPIRON
K
10
3578
PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST
K
09
1853
WRIGHT RESPIROMETER, MARK 8, AND 14 RESPIROMETER, MODEL 700-021, 700-008, 700-014
K
09
2217
MERCURY VCO2
K
09
1459
PHILIPS NM3 MONITOR, MODEL 7900
K
08
0652
MERCURY VCO2 MODULE WITH CAPNOSTAT 5
K
06
2754
GAS MODULE SE, MODEL 0998-00-0481-02
K
05
1279
CALDYNE, INC. EXHALOMETER EX100, MODEL EX100
K
98
3274
STARTRACK INFANT GRAPHICS MONITOR
K
97
2086
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS311
K
93
2098
CAPNOMAC ULTIMA ANESTHESIA MONITOR
K
93
1542
NEWPORT COMPASS EXHALED TIDAL VOLUME MONITOR
K
92
1717
BICORE SMARTVALVE OCCLUSION VALVE
K
90
3674
MODEL 295 ELECTRONIC RESPIROMETER
K
90
3959
NEONATAL METASCOPE
K
90
1885
PARTNER VOLUME MONITOR
K
89
0932
CAV 3.0C SOFTWARE PROGRAM
K
88
4910
MODEL 1010, CY-MET
K
88
4959
RESPITRAK
K
88
4942
MONAGHAN RVM, MODEL 761
K
89
0724
MOFIFICATION BEAR NVM-1 NEONATAL VOLUME MONITOR
K
87
2660
BEAR NVM-1
K
86
4886
RESPIGRAPH-RESPISOMNOGRAPH-RESPICENTRAL
K
86
3866
RESPIRADYNE II(TM)
K
86
3538
RESPICENTRAL(TM)
K
86
2687
OHMEDA 5410 VOLUME MONITOR
K
86
2688
OHMEDA 5420 VOLUME MONITOR
K
85
4956
RESPIGRAPH
K
85
3346
BEAR NICU-1
K
85
2692
RESPITRACE 300SC
K
84
3799
OHMEDA RM311 RESPIROMETER
K
84
3800
OHMEDA RM121 RESPIROMETER
K
84
0975
RICO RESPIRATION MONITOR
K
84
0453
MEDISHIELD PVM RESPIROMETER
K
82
3780
RESPITRACE 300SC
K
82
3783
RESPICOMB
K
83
2565
OHIO 5400 VOLUME MONITOR
K
82
2689
PORTABLE MONITORING & SCREENING SPIROM.
K
83
1237
SPIROMED RESPIROMETER
K
83
0995
POCKET SPIROMETER
K
82
3782
RESPITRACE SYSTEM
K
82
3922
COMPUTERIZED SPIROMETRY SYSTEM
K
82
3555
MAGTARAK RESPIRATORY MONITOR & FLOW SENS
K
82
2912
BEAR VM-90 VENTILATION MONITOR
K
81
2956
SPIROX H
K
81
2959
SPIROX A
K
81
2046
TIDAL VOLUME MONITOR 150
K
80
0086
RMS 111F RESPIRATORY MONITORING SYSTEM
K
79
2573
ALARM USED W/MONITORING SPIROMETER
K
79
2572
EMPIRE SPIROMETER
K
78
2145
SPIROMETER, MINI POSITIVE
K
78
0064
SPIROMETER, MONITORING W/ALARM
K
77
2016
RESPITRACE
K
77
0907
SPIROMETEO EXHAUST
K
76
0971
POSITIVE DISPLACEMENT SPIROMETER
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
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
/
BZK
/
K843799
View Source
OHMEDA RM311 RESPIROMETER
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K843799
510(k) Type
Traditional
Applicant
OHMEDA MEDICAL
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/4/1984
Days to Decision
7 days