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
K
20
0076
Breezing Med
2
Cleared 510(K)
K
19
0561
NICU V'02
2
Cleared 510(K)
K
11
0810
ANASCIENT BREATH MONITOR
2
Cleared 510(K)
K
09
3080
METAPHOR METABOLIC MONITOR
2
Cleared 510(K)
K
07
1533
FITMATE SERIES
2
Cleared 510(K)
K
07
0858
EXPRESS SERIES
2
Cleared 510(K)
K
06
1731
MEDGRAPHICS ULTIMA SYSTEM
2
Cleared 510(K)
K
02
1490
REEVUE INDIRECT CALORIMETER, MODEL#8100
2
Cleared 510(K)
K
02
1605
MEDGEM
2
Cleared 510(K)
K
01
0577
BODYGEM, MODEL HB211
2
Cleared 510(K)
K
95
4731
OXYLOG 2
2
Cleared 510(K)
K
92
4978
7250 METABOLIC MONITOR
2
Cleared 510(K)
K
92
1565
CARDIOPULMONARY METABOLIC MEASUEMENT CART
2
Cleared 510(K)
K
93
1422
DELTATRAC(TM) II METABOLIC MONITOR
2
Cleared 510(K)
K
92
2660
PHYSIO-DYNE EASI - LAB
2
Cleared 510(K)
K
91
2906
MEDGRAPHICS PF/DX
2
Cleared 510(K)
K
89
5791
OXYMAX
2
Cleared 510(K)
K
89
5935
ICOR CMU Q PLUS
2
Cleared 510(K)
K
89
5586
VVR/Q CALORIMETER
2
Cleared 510(K)
K
87
4663
MOXUS OR OCM-1 OXYGEN UPTAKE SYSTEM
2
Cleared 510(K)
K
86
4603
DELTATRAC(TM) METABOLIC MONITOR
2
Cleared 510(K)
K
86
4852
VISTA INTERFACE SYSTEM
2
Cleared 510(K)
K
85
4927
ICOR CALARIC MEASUREMENT UNIT (CMU)
2
Cleared 510(K)
K
85
3434
ERGO-PNEUMOTEST
2
Cleared 510(K)
K
83
3714
RESPIRATORY ASSESSMENT SYSTEM
2
Cleared 510(K)
K
83
1780
METABOLIC EXERCISE TESTING SYSTEM
2
Cleared 510(K)
K
82
3695
CPM METABOLIC MONITOR
2
Cleared 510(K)
K
82
2710
METABOLIC MEASUREMENT CART
2
Cleared 510(K)
K
82
1344
ENGSTROM METABOLIC COMPUTER
2
Cleared 510(K)
K
82
0905
BECKMAN MMC II METABOLIC MEAS. CART
2
Cleared 510(K)
K
82
0475
MGC/LITTON 2300
2
Cleared 510(K)
K
80
2417
AB O2 CONSUMPTION CALCULATOR 980
2
Cleared 510(K)
K
80
1852
MRM-2 OXYGEN CONSUMPTION MONITOR
2
Cleared 510(K)
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 6 December 2024 at 11:05 pm
AN
/
subpart-b—diagnostic-devices
/
BZL
/
K922660
View Source
PHYSIO-DYNE EASI - LAB
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K922660
510(k) Type
Traditional
Applicant
PHYSIO-DYNE
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/8/1993
Days to Decision
309 days
Submission Type
Statement
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
K
20
0076
Breezing Med
K
19
0561
NICU V'02
K
11
0810
ANASCIENT BREATH MONITOR
K
09
3080
METAPHOR METABOLIC MONITOR
K
07
1533
FITMATE SERIES
K
07
0858
EXPRESS SERIES
K
06
1731
MEDGRAPHICS ULTIMA SYSTEM
K
02
1490
REEVUE INDIRECT CALORIMETER, MODEL#8100
K
02
1605
MEDGEM
K
01
0577
BODYGEM, MODEL HB211
K
95
4731
OXYLOG 2
K
92
4978
7250 METABOLIC MONITOR
K
92
1565
CARDIOPULMONARY METABOLIC MEASUEMENT CART
K
93
1422
DELTATRAC(TM) II METABOLIC MONITOR
K
92
2660
PHYSIO-DYNE EASI - LAB
K
91
2906
MEDGRAPHICS PF/DX
K
89
5791
OXYMAX
K
89
5935
ICOR CMU Q PLUS
K
89
5586
VVR/Q CALORIMETER
K
87
4663
MOXUS OR OCM-1 OXYGEN UPTAKE SYSTEM
K
86
4603
DELTATRAC(TM) METABOLIC MONITOR
K
86
4852
VISTA INTERFACE SYSTEM
K
85
4927
ICOR CALARIC MEASUREMENT UNIT (CMU)
K
85
3434
ERGO-PNEUMOTEST
K
83
3714
RESPIRATORY ASSESSMENT SYSTEM
K
83
1780
METABOLIC EXERCISE TESTING SYSTEM
K
82
3695
CPM METABOLIC MONITOR
K
82
2710
METABOLIC MEASUREMENT CART
K
82
1344
ENGSTROM METABOLIC COMPUTER
K
82
0905
BECKMAN MMC II METABOLIC MEAS. CART
K
82
0475
MGC/LITTON 2300
K
80
2417
AB O2 CONSUMPTION CALCULATOR 980
K
80
1852
MRM-2 OXYGEN CONSUMPTION MONITOR
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
/
BZL
/
K922660
View Source
PHYSIO-DYNE EASI - LAB
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K922660
510(k) Type
Traditional
Applicant
PHYSIO-DYNE
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/8/1993
Days to Decision
309 days
Submission Type
Statement