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FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular Diagnostic Devices
CFR Sub-Part
Cardiovascular Monitoring Devices
CFR Sub-Part
Cardiovascular Therapeutic Devices
CFR Sub-Part
Diagnostic Devices
CFR Sub-Part
Miscellaneous
CFR Sub-Part
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
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
K
21
0593
Onera Sleep Test System (Onera STS)
2
Cleared 510(K)
K
20
3839
WatchPAT200U (WP200U)
2
Cleared 510(K)
K
22
0028
NightOwl
2
Cleared 510(K)
K
20
3343
Wesper Lab
2
Cleared 510(K)
K
21
3463
NightOwl
2
Cleared 510(K)
K
21
0480
AcuPebble SA
2
Cleared 510(K)
K
20
1495
Maxxi Flow Sensor
2
Cleared 510(K)
K
20
0695
MATRx plus
2
Cleared 510(K)
K
20
0654
Rubicon SA System
2
Cleared 510(K)
K
19
1031
NightOwl
2
Cleared 510(K)
Show All 134 Submissions
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
Neurological Therapeutic Devices
CFR Sub-Part
Physical Medicine Therapeutic Devices
CFR Sub-Part
Prosthetic Devices
CFR Sub-Part
Surgical Devices
CFR Sub-Part
Therapeutic Devices
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 17 March 2023 at 11:04 pm
AN
/
monitoring-devices
/
MNR
/
K191031
View Source
NightOwl
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K191031
510(k) Type
Traditional
Applicant
Ectosense nv
Country
Belgium
FDA Decision
Substantially Equivalent
Decision Date
3/6/2020
Days to Decision
323 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular Diagnostic Devices
Cardiovascular Monitoring Devices
Cardiovascular Therapeutic Devices
Diagnostic Devices
Miscellaneous
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)
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
K
21
0593
Onera Sleep Test System (Onera STS)
K
20
3839
WatchPAT200U (WP200U)
K
22
0028
NightOwl
K
20
3343
Wesper Lab
K
21
3463
NightOwl
K
21
0480
AcuPebble SA
K
20
1495
Maxxi Flow Sensor
K
20
0695
MATRx plus
K
20
0654
Rubicon SA System
K
19
1031
NightOwl
Show All 134 Submissions
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
Neurological Therapeutic Devices
Physical Medicine Therapeutic Devices
Prosthetic Devices
Surgical Devices
Therapeutic Devices
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
/
monitoring-devices
/
MNR
/
K191031
View Source
NightOwl
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K191031
510(k) Type
Traditional
Applicant
Ectosense nv
Country
Belgium
FDA Decision
Substantially Equivalent
Decision Date
3/6/2020
Days to Decision
323 days
Submission Type
Summary