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by
Innolitics
Anesthesiology
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart C—Monitoring Devices
CFR Sub-Part
BXH
Gauge, Gas Pressure, Cylinder/Pipeline
1
Product Code
BXM
Stimulator, Nerve, Ac-Powered
2
Product Code
BXN
Stimulator, Nerve, Battery-Powered
2
Product Code
BXO
Transducer, Gas Pressure
1
Product Code
BXP
Transducer, Gas Flow
1
Product Code
BXX
Calibrator, Pressure, Gas
1
Product Code
BXY
Flowmeter, Calibration, Gas
1
Product Code
BYM
Tube, Thorpe, Uncompensated
1
Product Code
BYR
Transducer, Gas Pressure, Differential
1
Product Code
BZQ
Monitor, Breathing Frequency
2
Product Code
CAN
Regulator, Pressure, Gas Cylinder
1
Product Code
CAP
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
2
Product Code
K
20
1666
SINGLE USE MANOMETER
2
Cleared 510(K)
K
18
2292
VORTRAN APM-Plus
2
Cleared 510(K)
K
18
0510
NS 120P-TRS Airway Pressure Gauge
2
Cleared 510(K)
K
17
2284
NAPA LP-15 Airway Pressure Monitor
2
Cleared 510(K)
K
15
3733
VORTRAN Manometer
2
Cleared 510(K)
K
14
3148
Disposable Pressure Manometer (DPM)
2
Cleared 510(K)
K
14
0370
DISPOSABLE PRESSURE MANOMETER
2
Cleared 510(K)
K
12
2627
GIO DIGITAL PRESSURE GUAGES
2
Cleared 510(K)
K
12
2077
MANOMETER
2
Cleared 510(K)
K
12
0118
VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER
2
Cleared 510(K)
K
10
3639
VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY PRESSURE MONITOR (VAPM)- PEDIATRIC
2
Cleared 510(K)
K
11
0119
PRESSURE MANOMETER
2
Cleared 510(K)
K
10
2377
VENTIPLUS DISPOSABLE MANOMETER 0-60 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0-20 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0
2
Cleared 510(K)
K
08
1778
NS SERIES VACUUM/PRESSURE GAUGES, CUFF PRESSURE MONITORS
2
Cleared 510(K)
K
05
0309
PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000
2
Cleared 510(K)
K
04
0991
AMBU DISPOSABLE PRESSURE MANOMETER
2
Cleared 510(K)
K
02
2402
DISPOSABLE PRESSURE MANOMETER
2
Cleared 510(K)
K
00
3497
DISPOSABLE PRESSURE MONITOR
2
Cleared 510(K)
K
00
0959
CRITERION 60 OR PM 60
2
Cleared 510(K)
K
99
2101
CRITERION 40 OR PM 40
2
Cleared 510(K)
K
97
3347
TSX PRM PULMONARY RESUSCITATION MONITOR
2
Cleared 510(K)
K
96
1318
1ST RESPONSE DISPOSABLE MANOMETER
2
Cleared 510(K)
K
95
4486
MERCURY AIRWAY PRESSURE MANOMETER
2
Cleared 510(K)
K
93
6009
AMS 3000M
2
Cleared 510(K)
K
94
3146
PORTA-RESP MONITOR
2
Cleared 510(K)
K
94
0375
MICRO MPM
2
Cleared 510(K)
K
93
1394
CM5000R REMOTE INDICATOR
2
Cleared 510(K)
K
93
1287
CM7000 REMOTE INDICATOR
2
Cleared 510(K)
K
92
5673
AIRWAY PRESSURE MONITOR CM 5000 NGAN
2
Cleared 510(K)
K
92
1978
BREATH TRACKER(TM) MODEL 1800 CAN-O-GAUGE
2
Cleared 510(K)
K
90
4935
RESPIRONICS' DIGITAL MANOMETER
2
Cleared 510(K)
N
83
074
NON-ABSORBABLE BLACK SILK SUTURE
2
PMA Approval
K
90
2381
PENLON BREATHING SYSTEM PRESSURE MONITOR
2
Cleared 510(K)
K
90
2276
RESPIRONICS BIPAP PRESSURE ALARM (BIPAP P.A.)
2
Cleared 510(K)
K
89
6136
INFANT C.P.A.P. MONITOR
2
Cleared 510(K)
K
89
5747
VENTILARM II PORTABLE AIRWAY PRESSURE MONITOR
2
Cleared 510(K)
K
89
4361
LIFECARE PRESSURE ALARM CAT. NO. 34-010
2
Cleared 510(K)
K
89
4689
PENLON IDP PRESSURE FAILURE ALARM
2
Cleared 510(K)
K
89
2942
BREATH TRACKER
2
Cleared 510(K)
K
89
0010
CM 7000MR
2
Cleared 510(K)
K
87
3953
CM 5000R REMOTE AIRWAY PRESSURE
2
Cleared 510(K)
K
87
1336
M-1 PRESSURE MONITOR
2
Cleared 510(K)
K
87
1139
M-10 VENTILATION MONITOR
2
Cleared 510(K)
K
87
1083
CM 5000 MONITOR AIRWAY PRESSURE
2
Cleared 510(K)
K
86
4536
OHMEDA 5500 AIRWAY PRESSURE MONITOR
2
Cleared 510(K)
N
83
074
NON-ABSORBABLE BLACK SILK SUTURE
2
PMA Approval
K
86
1720
MODIFIED BAROMED BREATHING PRESSURE MONITOR
2
Cleared 510(K)
K
86
1330
SECHRIST AIRWAY PRESSURE MONITOR MODEL 600
2
Cleared 510(K)
K
85
4934
VENTILATOR PRESSURE ALARM MODEL VPA-100
2
Cleared 510(K)
K
85
2826
AN PRESSURE MONITOR
2
Cleared 510(K)
K
85
2824
PMA PRESSURE MONITOR
2
Cleared 510(K)
K
85
1905
LPA-2 REMOTE ALARM
2
Cleared 510(K)
N
83
074
NON-ABSORBABLE BLACK SILK SUTURE
2
PMA Approval
K
84
0420
AIRWAY PRESSURE MONITOR
2
Cleared 510(K)
K
84
0279
DRAGER BAROMED
2
Cleared 510(K)
K
83
2271
EMERSON MODEL 3MV-AP AND 3V-AP PRESS-
2
Cleared 510(K)
K
82
1649
MONAGHAN'S PRESSURE ALARM
2
Cleared 510(K)
K
82
1667
SINGLE USE NON-CONDUCTIVE CIRC. DISCON
2
Cleared 510(K)
K
82
0720
RESPIRATOR MONITOR
2
Cleared 510(K)
K
82
0353
MONITRON MODEL JL-7
2
Cleared 510(K)
K
81
2960
EAST VENTILARM PRESSURE MONITOR ALARM S.
2
Cleared 510(K)
K
81
2041
VENTI-MONITOR MODEL 101
2
Cleared 510(K)
K
81
2140
BIRD MEAN AIRWAY PRESSURE MONITOR
2
Cleared 510(K)
K
81
0753
AIRWAY PRESSURE MONITOR
2
Cleared 510(K)
K
81
0648
SECHRIST AIRWAY PRESSURE MONITOR #400
2
Cleared 510(K)
K
81
0547
BLSI VENTILATION MONITOR
2
Cleared 510(K)
K
81
0255
MEAN PRESSURE MONITOR
2
Cleared 510(K)
K
80
2955
MONITOR, AIRWAY PRESSURE
2
Cleared 510(K)
K
80
2054
TRAVENOL ULTRASONIC NEBULIZER CUPS
2
Cleared 510(K)
K
80
2565
3MP-7 SCANNER RESPIRATORY MONITOR
2
Cleared 510(K)
K
80
2090
DRAGER PRESSURE MONITOR, SELF-DIAGNOSTIC
2
Cleared 510(K)
K
80
1254
PENLON I.D.P. PRESSSURE FAILURE ALARM
2
Cleared 510(K)
K
79
2515
RESPIRATOR DISCONNECT ALARM
2
Cleared 510(K)
K
79
2516
RESPIRATOR DISCONNECT ALARM CR 201
2
Cleared 510(K)
K
79
1561
RESPIRATOR DISCONNECT ALARM VA-100
2
Cleared 510(K)
K
79
1527
RESPIRATOR DISCONNECT ALARM CR201
2
Cleared 510(K)
K
79
0370
BUNN MODEL #40 LOW PRESSURE ALARM
2
Cleared 510(K)
K
78
2174
PRESSURE ALARM
2
Cleared 510(K)
K
78
1714
PNEUMOGARD MODEL 1230
2
Cleared 510(K)
K
78
1697
PRESSURE, LOW/HIGH MODEL C1070
2
Cleared 510(K)
K
78
0863
MODEL 65 HIGH & LOW PRESSURE ALARM
2
Cleared 510(K)
CAX
Flowmeter, Tube, Thorpe, Back-Pressure Compensated
1
Product Code
CBA
Monitor, Air Embolism, Ultrasonic
2
Product Code
CCN
Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge
1
Product Code
ECX
Cylinder, Compressed Gas, And Valve
1
Product Code
FLS
Monitor, Apnea, Facility Use
2
Product Code
JAX
Pneumotachometer
2
Product Code
JEZ
Monitor, Lung Water Measurement
3
Product Code
KLK
Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
2
Product Code
KOI
Stimulator, Nerve, Peripheral, Electric
2
Product Code
LKD
Monitor, Carbon-Dioxide, Cutaneous
2
Product Code
LPP
Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia
2
Product Code
MNR
Ventilatory Effort Recorder
2
Product Code
MRP
Analyzer, Nitric Oxide
2
Product Code
MRQ
Analyzer, Nitrogen Dioxide
2
Product Code
NPF
Monitor, Apnea, Home Use
2
Product Code
PRK
Device Indicating An Exhalation Event
2
Product Code
PUG
Analyzer, Nitrogen Dioxide, Exempt
2
Product Code
PXE
Pressure Monitoring (Air/Gas) Kit
1
Product Code
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 30 November 2024 at 11:09 am
AN
/
subpart-c—monitoring-devices
/
CAP
/
K821649
View Source
MONAGHAN'S PRESSURE ALARM
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K821649
510(k) Type
Traditional
Applicant
MONAGHAN MEDICAL CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/5/1982
Days to Decision
62 days
FDA Browser
by
Innolitics
Anesthesiology
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart C—Monitoring Devices
BXH
Gauge, Gas Pressure, Cylinder/Pipeline
BXM
Stimulator, Nerve, Ac-Powered
BXN
Stimulator, Nerve, Battery-Powered
BXO
Transducer, Gas Pressure
BXP
Transducer, Gas Flow
BXX
Calibrator, Pressure, Gas
BXY
Flowmeter, Calibration, Gas
BYM
Tube, Thorpe, Uncompensated
BYR
Transducer, Gas Pressure, Differential
BZQ
Monitor, Breathing Frequency
CAN
Regulator, Pressure, Gas Cylinder
CAP
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
K
20
1666
SINGLE USE MANOMETER
K
18
2292
VORTRAN APM-Plus
K
18
0510
NS 120P-TRS Airway Pressure Gauge
K
17
2284
NAPA LP-15 Airway Pressure Monitor
K
15
3733
VORTRAN Manometer
K
14
3148
Disposable Pressure Manometer (DPM)
K
14
0370
DISPOSABLE PRESSURE MANOMETER
K
12
2627
GIO DIGITAL PRESSURE GUAGES
K
12
2077
MANOMETER
K
12
0118
VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER
K
10
3639
VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY PRESSURE MONITOR (VAPM)- PEDIATRIC
K
11
0119
PRESSURE MANOMETER
K
10
2377
VENTIPLUS DISPOSABLE MANOMETER 0-60 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0-20 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0
K
08
1778
NS SERIES VACUUM/PRESSURE GAUGES, CUFF PRESSURE MONITORS
K
05
0309
PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000
K
04
0991
AMBU DISPOSABLE PRESSURE MANOMETER
K
02
2402
DISPOSABLE PRESSURE MANOMETER
K
00
3497
DISPOSABLE PRESSURE MONITOR
K
00
0959
CRITERION 60 OR PM 60
K
99
2101
CRITERION 40 OR PM 40
K
97
3347
TSX PRM PULMONARY RESUSCITATION MONITOR
K
96
1318
1ST RESPONSE DISPOSABLE MANOMETER
K
95
4486
MERCURY AIRWAY PRESSURE MANOMETER
K
93
6009
AMS 3000M
K
94
3146
PORTA-RESP MONITOR
K
94
0375
MICRO MPM
K
93
1394
CM5000R REMOTE INDICATOR
K
93
1287
CM7000 REMOTE INDICATOR
K
92
5673
AIRWAY PRESSURE MONITOR CM 5000 NGAN
K
92
1978
BREATH TRACKER(TM) MODEL 1800 CAN-O-GAUGE
K
90
4935
RESPIRONICS' DIGITAL MANOMETER
N
83
074
NON-ABSORBABLE BLACK SILK SUTURE
K
90
2381
PENLON BREATHING SYSTEM PRESSURE MONITOR
K
90
2276
RESPIRONICS BIPAP PRESSURE ALARM (BIPAP P.A.)
K
89
6136
INFANT C.P.A.P. MONITOR
K
89
5747
VENTILARM II PORTABLE AIRWAY PRESSURE MONITOR
K
89
4361
LIFECARE PRESSURE ALARM CAT. NO. 34-010
K
89
4689
PENLON IDP PRESSURE FAILURE ALARM
K
89
2942
BREATH TRACKER
K
89
0010
CM 7000MR
K
87
3953
CM 5000R REMOTE AIRWAY PRESSURE
K
87
1336
M-1 PRESSURE MONITOR
K
87
1139
M-10 VENTILATION MONITOR
K
87
1083
CM 5000 MONITOR AIRWAY PRESSURE
K
86
4536
OHMEDA 5500 AIRWAY PRESSURE MONITOR
N
83
074
NON-ABSORBABLE BLACK SILK SUTURE
K
86
1720
MODIFIED BAROMED BREATHING PRESSURE MONITOR
K
86
1330
SECHRIST AIRWAY PRESSURE MONITOR MODEL 600
K
85
4934
VENTILATOR PRESSURE ALARM MODEL VPA-100
K
85
2826
AN PRESSURE MONITOR
K
85
2824
PMA PRESSURE MONITOR
K
85
1905
LPA-2 REMOTE ALARM
N
83
074
NON-ABSORBABLE BLACK SILK SUTURE
K
84
0420
AIRWAY PRESSURE MONITOR
K
84
0279
DRAGER BAROMED
K
83
2271
EMERSON MODEL 3MV-AP AND 3V-AP PRESS-
K
82
1649
MONAGHAN'S PRESSURE ALARM
K
82
1667
SINGLE USE NON-CONDUCTIVE CIRC. DISCON
K
82
0720
RESPIRATOR MONITOR
K
82
0353
MONITRON MODEL JL-7
K
81
2960
EAST VENTILARM PRESSURE MONITOR ALARM S.
K
81
2041
VENTI-MONITOR MODEL 101
K
81
2140
BIRD MEAN AIRWAY PRESSURE MONITOR
K
81
0753
AIRWAY PRESSURE MONITOR
K
81
0648
SECHRIST AIRWAY PRESSURE MONITOR #400
K
81
0547
BLSI VENTILATION MONITOR
K
81
0255
MEAN PRESSURE MONITOR
K
80
2955
MONITOR, AIRWAY PRESSURE
K
80
2054
TRAVENOL ULTRASONIC NEBULIZER CUPS
K
80
2565
3MP-7 SCANNER RESPIRATORY MONITOR
K
80
2090
DRAGER PRESSURE MONITOR, SELF-DIAGNOSTIC
K
80
1254
PENLON I.D.P. PRESSSURE FAILURE ALARM
K
79
2515
RESPIRATOR DISCONNECT ALARM
K
79
2516
RESPIRATOR DISCONNECT ALARM CR 201
K
79
1561
RESPIRATOR DISCONNECT ALARM VA-100
K
79
1527
RESPIRATOR DISCONNECT ALARM CR201
K
79
0370
BUNN MODEL #40 LOW PRESSURE ALARM
K
78
2174
PRESSURE ALARM
K
78
1714
PNEUMOGARD MODEL 1230
K
78
1697
PRESSURE, LOW/HIGH MODEL C1070
K
78
0863
MODEL 65 HIGH & LOW PRESSURE ALARM
CAX
Flowmeter, Tube, Thorpe, Back-Pressure Compensated
CBA
Monitor, Air Embolism, Ultrasonic
CCN
Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge
ECX
Cylinder, Compressed Gas, And Valve
FLS
Monitor, Apnea, Facility Use
JAX
Pneumotachometer
JEZ
Monitor, Lung Water Measurement
KLK
Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
KOI
Stimulator, Nerve, Peripheral, Electric
LKD
Monitor, Carbon-Dioxide, Cutaneous
LPP
Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia
MNR
Ventilatory Effort Recorder
MRP
Analyzer, Nitric Oxide
MRQ
Analyzer, Nitrogen Dioxide
NPF
Monitor, Apnea, Home Use
PRK
Device Indicating An Exhalation Event
PUG
Analyzer, Nitrogen Dioxide, Exempt
PXE
Pressure Monitoring (Air/Gas) Kit
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-c—monitoring-devices
/
CAP
/
K821649
View Source
MONAGHAN'S PRESSURE ALARM
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K821649
510(k) Type
Traditional
Applicant
MONAGHAN MEDICAL CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/5/1982
Days to Decision
62 days