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
K
10
2229
PULMOTRACK 2020 SYSTEM
2
Cleared 510(K)
K
09
0863
PERSONAL WHEEZOMETER
2
Cleared 510(K)
K
07
1955
WIM-PC, MODEL 1010
2
Cleared 510(K)
K
01
2387
STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEM
2
Cleared 510(K)
K
98
0878
PULMOTRACK,MODEL 1010
2
Cleared 510(K)
K
97
4200
ORCA CARDIOPULMONARY EXERCISE TESTING SYSTEM
2
Cleared 510(K)
K
95
5432
CPX, CCM, CATH WITH 15% CO2
2
Cleared 510(K)
K
92
3209
MEDGRAPHICS EXERCISE CONSULT
2
Cleared 510(K)
K
91
1143
PB100 DIAGNOSTIC SPIROMETER
2
Cleared 510(K)
K
89
6345
EXERCISE EVALUATION SYSTEM 2010
2
Cleared 510(K)
K
88
0550
BURROWS-KNUDSON AUTOMATED LUNG FUNCTION INTER. SYS
2
Cleared 510(K)
K
87
4902
SINGLE BREATH LUNG DIFFUS TEST DEVICE SPIROMETERY
2
Cleared 510(K)
K
87
1711
MEDICAL GRAPHICS DESKTOP DIAGNOSTIC SYSTEM
2
Cleared 510(K)
K
86
4911
EXERSYSTEM(TM) MMC 5000
2
Cleared 510(K)
K
86
4885
SPIROVISION
2
Cleared 510(K)
K
86
3953
SPIROMETRICS MODEL 2500 FLOWMATE(TM)
2
Cleared 510(K)
K
86
1929
PULMONARY FUNCTION TEST LABORATORY, SYSTEM 1070
2
Cleared 510(K)
K
85
3190
SUPERSPIRO
2
Cleared 510(K)
K
85
1706
UNIVERSAL COMPUTER INTERFACE SYSTEM
2
Cleared 510(K)
K
84
2782
PHYSIOLOGICAL ANALYZER CM-710
2
Cleared 510(K)
K
83
1586
CM-VII PHYSIOLOGIC ANALYZER
2
Cleared 510(K)
K
82
0035
CDX 200
2
Cleared 510(K)
K
80
1496
PULMONARY LAB AUTOMATION SYSTEM
2
Cleared 510(K)
K
80
1495
CARDIO-PULMONARY EXERCISE STRESS SYSTEM
2
Cleared 510(K)
K
79
1229
CYBER DX 100
2
Cleared 510(K)
K
77
1371
SCREENING COMPUTEO SC-20
2
Cleared 510(K)
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
/
BZM
/
K864885
View Source
SPIROVISION
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K864885
510(k) Type
Traditional
Applicant
FUTUREMED DIV. OF FUTURE IMPEX CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/15/1987
Days to Decision
34 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)
K
10
2229
PULMOTRACK 2020 SYSTEM
K
09
0863
PERSONAL WHEEZOMETER
K
07
1955
WIM-PC, MODEL 1010
K
01
2387
STG MULTICHANNEL LUNG SOUND ANALYSIS SYSTEM
K
98
0878
PULMOTRACK,MODEL 1010
K
97
4200
ORCA CARDIOPULMONARY EXERCISE TESTING SYSTEM
K
95
5432
CPX, CCM, CATH WITH 15% CO2
K
92
3209
MEDGRAPHICS EXERCISE CONSULT
K
91
1143
PB100 DIAGNOSTIC SPIROMETER
K
89
6345
EXERCISE EVALUATION SYSTEM 2010
K
88
0550
BURROWS-KNUDSON AUTOMATED LUNG FUNCTION INTER. SYS
K
87
4902
SINGLE BREATH LUNG DIFFUS TEST DEVICE SPIROMETERY
K
87
1711
MEDICAL GRAPHICS DESKTOP DIAGNOSTIC SYSTEM
K
86
4911
EXERSYSTEM(TM) MMC 5000
K
86
4885
SPIROVISION
K
86
3953
SPIROMETRICS MODEL 2500 FLOWMATE(TM)
K
86
1929
PULMONARY FUNCTION TEST LABORATORY, SYSTEM 1070
K
85
3190
SUPERSPIRO
K
85
1706
UNIVERSAL COMPUTER INTERFACE SYSTEM
K
84
2782
PHYSIOLOGICAL ANALYZER CM-710
K
83
1586
CM-VII PHYSIOLOGIC ANALYZER
K
82
0035
CDX 200
K
80
1496
PULMONARY LAB AUTOMATION SYSTEM
K
80
1495
CARDIO-PULMONARY EXERCISE STRESS SYSTEM
K
79
1229
CYBER DX 100
K
77
1371
SCREENING COMPUTEO SC-20
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
/
BZM
/
K864885
View Source
SPIROVISION
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K864885
510(k) Type
Traditional
Applicant
FUTUREMED DIV. OF FUTURE IMPEX CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/15/1987
Days to Decision
34 days