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
K
23
0423
Electronic Peak Flow Meter
2
Cleared 510(K)
K
22
2810
TD-7301 Peak Flow meter
2
Cleared 510(K)
K
20
3196
Peak flow meter
2
Cleared 510(K)
K
20
0832
Safey Peak Flow Meter
2
Cleared 510(K)
K
19
3311
Aluna
2
Cleared 510(K)
K
19
1239
Smart Peak Flow Meter
2
Cleared 510(K)
K
18
0487
Peak.me
2
Cleared 510(K)
K
18
1666
Smart One
2
Cleared 510(K)
K
17
2804
Besmed Peak Flow Meter
2
Cleared 510(K)
K
17
0281
MSA100BT Peak Flow Meter
2
Cleared 510(K)
K
15
2276
Wing Smart FEVI and Peak Flow Meter
2
Cleared 510(K)
K
13
3975
MSA100 PEAK FLOW METER
2
Cleared 510(K)
K
12
3945
STRIVE DUAL ZONE PEAK FLOW METER
2
Cleared 510(K)
K
10
1380
RXPEAKFLOW
2
Cleared 510(K)
K
09
2335
PEAK EXPIRATORY FLOW METER, KN-9710
2
Cleared 510(K)
K
09
1412
CLEAN PEAK FLOW METER
2
Cleared 510(K)
K
08
2899
DYNAMIPEAK PEAK FLOW METER
2
Cleared 510(K)
K
05
3156
MINI-WRIGHT DIGITAL, MODEL 3120001
2
Cleared 510(K)
K
05
0853
PMP4 SPIROPRO
2
Cleared 510(K)
K
04
0723
MICROLIFE ELECTRONIC PEAK FLOW MONITOR, WITH PEF AND FEV1, MODELS PF-100 AND PF-100-1 (WITH SOFTWARE)
2
Cleared 510(K)
K
03
1024
MICROLIFE ELECTRONIC PEAK FLOW MONITOR, MODEL PF-100
2
Cleared 510(K)
K
03
0586
MICROPEAK
2
Cleared 510(K)
K
03
1514
MODIFICATION TO TRUPEAK PEAK FLOW METER
2
Cleared 510(K)
K
02
2124
GALEMED PEAK FLOW METER, MODELS 3751/3752
2
Cleared 510(K)
K
02
3097
TRUEZONE PEAK FLOW METER
2
Cleared 510(K)
K
01
3489
KP + LFM
2
Cleared 510(K)
K
01
0009
KOKO PEAK KP; KOKO PEAK KP+
2
Cleared 510(K)
K
98
0951
ONEFLOW
2
Cleared 510(K)
K
99
1412
VITALOGRAPH MICRO
2
Cleared 510(K)
K
99
2618
RESPALERT
2
Cleared 510(K)
K
99
1212
MODIFICATION TO TRUZONE PEAK FLOW METER
2
Cleared 510(K)
K
98
2334
AIRZONE PEAK FLOWMETER
2
Cleared 510(K)
K
98
2995
ACCUTRAX, MODEL EPF840
2
Cleared 510(K)
K
98
2676
AIRWATCH II ZONE
2
Cleared 510(K)
K
98
2675
AIRWATCH II ZONELESS
2
Cleared 510(K)
K
98
0550
WHISTLE WATCH
2
Cleared 510(K)
K
98
0960
IN-CHECK INSPIRATORY FLOWMETER
2
Cleared 510(K)
K
98
0443
PEAK FLOW METER MINIMAX
2
Cleared 510(K)
K
97
0507
PEAK FLOW METER
2
Cleared 510(K)
K
96
1779
MINI-BELL PEAK FLOW METER/LOW RANGE MODEL PEAK FLOW METER
2
Cleared 510(K)
K
96
4130
AEROGEAR ASTHMA ACTION KIT
2
Cleared 510(K)
K
96
2074
VM PLUS PEAK FLOWMETER
2
Cleared 510(K)
K
96
3089
TRUZONE PEAK FLOW METER
2
Cleared 510(K)
K
96
3095
TRUPEAK PEAK FLOW METER
2
Cleared 510(K)
K
96
2924
PERSONAL BEST II WITH ZONE MANAGEMENT SYSTEM
2
Cleared 510(K)
K
96
2929
PERSONAL BEST II
2
Cleared 510(K)
K
95
3411
BREATH-TAKER BREATH-ALERT
2
Cleared 510(K)
K
95
2909
AUTOZONE
2
Cleared 510(K)
K
95
2713
MINI WRIGHT LR AFS
2
Cleared 510(K)
K
95
5234
TRUPEAK PEAK FLOW METER
2
Cleared 510(K)
K
95
5262
TRUZONE PEAK FLOW METER
2
Cleared 510(K)
K
95
4277
ASTECH PEAK FLOW METER
2
Cleared 510(K)
K
94
3678
ELECTRONIC FLOW METER
2
Cleared 510(K)
K
95
3458
RAINBOW STEP UP SYSTEMS INC. ASTHMA HOME CARE PLAN
2
Cleared 510(K)
K
93
4795
CARD GUARD
2
Cleared 510(K)
K
93
6110
ASPIRE
2
Cleared 510(K)
K
94
1226
AIRWATCH MONITOR
2
Cleared 510(K)
K
94
0836
PEAKLOG AND DISPLAY SOFTWARE
2
Cleared 510(K)
K
94
0835
PEAKLOG AND DISPLAY SOFTWARE
2
Cleared 510(K)
K
92
4322
FLOW=MED
2
Cleared 510(K)
K
93
4502
FLOW SPIROMETER
2
Cleared 510(K)
K
93
3889
PERSONAL BEST LOW RANGE
2
Cleared 510(K)
K
92
6307
PEAK FLOW METER
2
Cleared 510(K)
K
92
4343
WRIGHT POCKET PEAK FLOW METER
2
Cleared 510(K)
K
91
4126
VMX MINI-LOG FLOWMETER
2
Cleared 510(K)
K
92
0390
THE PEAK
2
Cleared 510(K)
K
91
5060
ASTECH HOME PEAK FLOW METER
2
Cleared 510(K)
K
91
2866
PEAK EXPIRATORY FLOW METER
2
Cleared 510(K)
K
91
5059
PEAK FLOW MONITOR
2
Cleared 510(K)
K
90
2292
MODIFIED ASSESS(R) PEAK FLOW METER
2
Cleared 510(K)
K
89
6953
MODIFIED ASSESS(R) PEAK FLOW METER
2
Cleared 510(K)
K
85
3922
PLOTTER FOR AS-500
2
Cleared 510(K)
K
85
1265
PEAK FLOWMETERS FOR SPIROMETRY
2
Cleared 510(K)
K
81
3414
PEAK FLOW MONITOR
2
Cleared 510(K)
K
78
1922
PULMONARY MONITOR
2
Cleared 510(K)
K
78
1224
METER, FLOW, PEAK
2
Cleared 510(K)
K
77
0580
PEAK FLOW METER
2
Cleared 510(K)
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
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
/
BZH
/
K781224
View Source
METER, FLOW, PEAK
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K781224
510(k) Type
Traditional
Applicant
PROJECTS IN HEALTH
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/15/1978
Days to Decision
90 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
K
23
0423
Electronic Peak Flow Meter
K
22
2810
TD-7301 Peak Flow meter
K
20
3196
Peak flow meter
K
20
0832
Safey Peak Flow Meter
K
19
3311
Aluna
K
19
1239
Smart Peak Flow Meter
K
18
0487
Peak.me
K
18
1666
Smart One
K
17
2804
Besmed Peak Flow Meter
K
17
0281
MSA100BT Peak Flow Meter
K
15
2276
Wing Smart FEVI and Peak Flow Meter
K
13
3975
MSA100 PEAK FLOW METER
K
12
3945
STRIVE DUAL ZONE PEAK FLOW METER
K
10
1380
RXPEAKFLOW
K
09
2335
PEAK EXPIRATORY FLOW METER, KN-9710
K
09
1412
CLEAN PEAK FLOW METER
K
08
2899
DYNAMIPEAK PEAK FLOW METER
K
05
3156
MINI-WRIGHT DIGITAL, MODEL 3120001
K
05
0853
PMP4 SPIROPRO
K
04
0723
MICROLIFE ELECTRONIC PEAK FLOW MONITOR, WITH PEF AND FEV1, MODELS PF-100 AND PF-100-1 (WITH SOFTWARE)
K
03
1024
MICROLIFE ELECTRONIC PEAK FLOW MONITOR, MODEL PF-100
K
03
0586
MICROPEAK
K
03
1514
MODIFICATION TO TRUPEAK PEAK FLOW METER
K
02
2124
GALEMED PEAK FLOW METER, MODELS 3751/3752
K
02
3097
TRUEZONE PEAK FLOW METER
K
01
3489
KP + LFM
K
01
0009
KOKO PEAK KP; KOKO PEAK KP+
K
98
0951
ONEFLOW
K
99
1412
VITALOGRAPH MICRO
K
99
2618
RESPALERT
K
99
1212
MODIFICATION TO TRUZONE PEAK FLOW METER
K
98
2334
AIRZONE PEAK FLOWMETER
K
98
2995
ACCUTRAX, MODEL EPF840
K
98
2676
AIRWATCH II ZONE
K
98
2675
AIRWATCH II ZONELESS
K
98
0550
WHISTLE WATCH
K
98
0960
IN-CHECK INSPIRATORY FLOWMETER
K
98
0443
PEAK FLOW METER MINIMAX
K
97
0507
PEAK FLOW METER
K
96
1779
MINI-BELL PEAK FLOW METER/LOW RANGE MODEL PEAK FLOW METER
K
96
4130
AEROGEAR ASTHMA ACTION KIT
K
96
2074
VM PLUS PEAK FLOWMETER
K
96
3089
TRUZONE PEAK FLOW METER
K
96
3095
TRUPEAK PEAK FLOW METER
K
96
2924
PERSONAL BEST II WITH ZONE MANAGEMENT SYSTEM
K
96
2929
PERSONAL BEST II
K
95
3411
BREATH-TAKER BREATH-ALERT
K
95
2909
AUTOZONE
K
95
2713
MINI WRIGHT LR AFS
K
95
5234
TRUPEAK PEAK FLOW METER
K
95
5262
TRUZONE PEAK FLOW METER
K
95
4277
ASTECH PEAK FLOW METER
K
94
3678
ELECTRONIC FLOW METER
K
95
3458
RAINBOW STEP UP SYSTEMS INC. ASTHMA HOME CARE PLAN
K
93
4795
CARD GUARD
K
93
6110
ASPIRE
K
94
1226
AIRWATCH MONITOR
K
94
0836
PEAKLOG AND DISPLAY SOFTWARE
K
94
0835
PEAKLOG AND DISPLAY SOFTWARE
K
92
4322
FLOW=MED
K
93
4502
FLOW SPIROMETER
K
93
3889
PERSONAL BEST LOW RANGE
K
92
6307
PEAK FLOW METER
K
92
4343
WRIGHT POCKET PEAK FLOW METER
K
91
4126
VMX MINI-LOG FLOWMETER
K
92
0390
THE PEAK
K
91
5060
ASTECH HOME PEAK FLOW METER
K
91
2866
PEAK EXPIRATORY FLOW METER
K
91
5059
PEAK FLOW MONITOR
K
90
2292
MODIFIED ASSESS(R) PEAK FLOW METER
K
89
6953
MODIFIED ASSESS(R) PEAK FLOW METER
K
85
3922
PLOTTER FOR AS-500
K
85
1265
PEAK FLOWMETERS FOR SPIROMETRY
K
81
3414
PEAK FLOW MONITOR
K
78
1922
PULMONARY MONITOR
K
78
1224
METER, FLOW, PEAK
K
77
0580
PEAK FLOW METER
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
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
/
BZH
/
K781224
View Source
METER, FLOW, PEAK
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K781224
510(k) Type
Traditional
Applicant
PROJECTS IN HEALTH
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/15/1978
Days to Decision
90 days