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Review Panel
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Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart B—Neurological Diagnostic Devices
CFR Sub-Part
GXW
Echoencephalograph
2
Product Code
GXX
Block, Test, Ultrasonic Scanner Calibration
1
Product Code
GXY
Electrode, Cutaneous
2
Product Code
GXZ
Electrode, Needle
2
Product Code
GYA
Tester, Electrode/Lead, Electroencephalograph
1
Product Code
GXS
Monitor, Alpha
2
Product Code
GWE
Stimulator, Photic, Evoked Response
2
Product Code
GWF
Stimulator, Electrical, Evoked Response
2
Product Code
GWG
Endoscope, Neurological
2
Product Code
GWI
Discriminator, Two-Point
1
Product Code
GWJ
Stimulator, Auditory, Evoked Response
2
Product Code
GWK
Conditioner, Signal, Physiological
2
Product Code
GWL
Amplifier, Physiological Signal
2
Product Code
GWM
Device, Monitoring, Intracranial Pressure
2
Product Code
GWN
Nystagmograph
2
Product Code
GWQ
Full-Montage Standard Electroencephalograph
2
Product Code
GWR
Generator, Electroencephalograph Test Signal
1
Product Code
GWS
Analyzer, Spectrum, Electroencephalogram Signal
1
Product Code
GWW
Ataxiagraph
1
Product Code
GWX
Fork, Tuning
1
Product Code
GWY
Pinwheel
1
Product Code
GWZ
Percussor
1
Product Code
GXB
Esthesiometer
1
Product Code
GYB
Media, Electroconductive
2
Product Code
GYC
Electrode, Cortical
2
Product Code
GYD
Transducer, Tremor
2
Product Code
GYE
Encephalogram Telemetry System
2
Product Code
GZK
Electrode, Nasopharyngeal
2
Product Code
GZL
Electrode, Depth
2
Product Code
GZM
Analyzer, Rigidity
2
Product Code
GZN
Rheoencephalograph
3
Product Code
GZO
Device, Galvanic Skin Response Measurement
2
Product Code
GZP
Stimulator, Mechanical, Evoked Response
2
Product Code
HCJ
Device, Skin Potential Measurement
2
Product Code
HCS
Device, Temperature Measurement, Direct Contact, Powered
2
Product Code
JXE
Device, Nerve Conduction Velocity Measurement
2
Product Code
JXF
Plethysmograph, Ocular
3
Product Code
LLN
Device, Vibration Threshold Measurement
1
Product Code
LQW
Test, Temperature Discrimination
1
Product Code
NCG
Neuropsychiatric Interpretative Electroencephalograph Assessment Aid
2
Product Code
NTU
Evoked Potential Stimulator, Thermal
2
Product Code
OLT
Non-Normalizing Quantitative Electroencephalograph Software
2
Product Code
OLU
Normalizing Quantitative Electroencephalograph Software
2
Product Code
OLV
Standard Polysomnograph With Electroencephalograph
2
Product Code
OLW
Index-Generating Electroencephalograph Software
2
Product Code
OLX
Source Localization Software For Electroencephalograph Or Magnetoencephalograph
2
Product Code
OLY
Magnetoencephalograph
2
Product Code
OLZ
Automatic Event Detection Software For Polysomnograph With Electroencephalograph
2
Product Code
K
24
2094
Dreem 3S
2
Cleared 510(K)
K
23
3438
SleepStageML
2
Cleared 510(K)
K
22
3539
Dreem 3S
2
Cleared 510(K)
K
22
3922
SOMNUM (V.1.1.2.)
2
Cleared 510(K)
K
22
1179
SomnoMetry
2
Cleared 510(K)
K
21
0034
EnsoSleep
2
Cleared 510(K)
K
20
2142
Sleepware G3
2
Cleared 510(K)
K
19
2469
Nox Sleep System
2
Cleared 510(K)
K
18
2227
Esprit Nova
2
Cleared 510(K)
K
17
3366
NicoletOne
2
Cleared 510(K)
K
16
3617
REMbrandt
2
Cleared 510(K)
K
16
2627
EnsoSleep
2
Cleared 510(K)
K
16
2140
RemLogic
2
Cleared 510(K)
K
15
3353
SANDMAN ELITE
2
Cleared 510(K)
K
15
3412
Sleep Profiler
2
Cleared 510(K)
K
14
2988
Sleepware G3
2
Cleared 510(K)
K
14
2825
Zmachine
2
Cleared 510(K)
K
13
0007
SLEEP PROFILER
2
Cleared 510(K)
K
12
0450
SLEEP PROFILER
2
Cleared 510(K)
K
09
0277
NATUS SLEEPWORKS, MODEL 104017
2
Cleared 510(K)
K
06
2943
POLYSMITH SLEEP SYSTEM, MODEL NTI5498
2
Cleared 510(K)
K
04
0595
ALICE 5
2
Cleared 510(K)
K
00
2622
BIOSLEEP
2
Cleared 510(K)
K
96
3631
SLEEP STUDY ANALYSIS (SSA) VERSION 96.10
2
Cleared 510(K)
K
96
1636
MEDILOG VISION
2
Cleared 510(K)
K
91
5856
SENSORMEDICS 4000 SERIES SLEEP SYSTEM
2
Cleared 510(K)
K
89
4155
SLEEPSCAN
2
Cleared 510(K)
K
89
1383
MEDILOG 9200 EEG REPLAY/ANALYSIS SYSTEM
2
Cleared 510(K)
K
89
0513
SAC 747 AND SAC 847 (SLEEP ANALYZING COMPUTERS)
2
Cleared 510(K)
K
87
1990
MODEL MPA MULTI PARAMETER ANALYSIS MONITORING SYS.
2
Cleared 510(K)
K
86
2527
SLEEP ANALYZING COMPUTER
2
Cleared 510(K)
OMA
Amplitude-Integrated Electroencephalograph
2
Product Code
OMB
Automatic Event Detection Software For Full-Montage Electroencephalograph
2
Product Code
OMC
Reduced- Montage Standard Electroencephalograph
2
Product Code
ORT
Burst Suppression Detection Software For Electroencephalograph
2
Product Code
PIW
Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid
2
Product Code
PKQ
Computerized Cognitive Assessment Aid
2
Product Code
PNA
Evoked Photon Image Capture Device
1
Product Code
POM
Computerized Cognitive Assessment Aid For Concussion
2
Product Code
POP
Cranial Motion Measurement Device
2
Product Code
POS
Physiological Signal Based Seizure Monitoring System
2
Product Code
PSP
Intracranial Pressure & Temperature Monitoring Kit
2
Product Code
PTB
Ataxiagraph With Interpretive Software
1
Product Code
PTY
Computerized Cognitive Assessment Aid, Exempt
2
Product Code
PVP
Neurological Test Kit
1
Product Code
QEA
Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid
2
Product Code
QPF
Pediatric Autism Spectrum Disorder Diagnosis Aid
2
Product Code
OPT
Infrared Hematoma Detector
2
Product Code
Subpart B—Physical Medicine Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart D—Physical Medicine Prosthetic Devices
CFR Sub-Part
Subpart E—Neurological Surgical 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
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
NE
/
subpart-b—neurological-diagnostic-devices
/
OLZ
/
K090277
View Source
NATUS SLEEPWORKS, MODEL 104017
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K090277
510(k) Type
Traditional
Applicant
EXCEL-TECH LTD. (XLTEK)
Country
Canada
FDA Decision
Substantially Equivalent
Decision Date
4/19/2011
Days to Decision
804 days
Submission Type
Statement
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
Subpart B—Neurological Diagnostic Devices
GXW
Echoencephalograph
GXX
Block, Test, Ultrasonic Scanner Calibration
GXY
Electrode, Cutaneous
GXZ
Electrode, Needle
GYA
Tester, Electrode/Lead, Electroencephalograph
GXS
Monitor, Alpha
GWE
Stimulator, Photic, Evoked Response
GWF
Stimulator, Electrical, Evoked Response
GWG
Endoscope, Neurological
GWI
Discriminator, Two-Point
GWJ
Stimulator, Auditory, Evoked Response
GWK
Conditioner, Signal, Physiological
GWL
Amplifier, Physiological Signal
GWM
Device, Monitoring, Intracranial Pressure
GWN
Nystagmograph
GWQ
Full-Montage Standard Electroencephalograph
GWR
Generator, Electroencephalograph Test Signal
GWS
Analyzer, Spectrum, Electroencephalogram Signal
GWW
Ataxiagraph
GWX
Fork, Tuning
GWY
Pinwheel
GWZ
Percussor
GXB
Esthesiometer
GYB
Media, Electroconductive
GYC
Electrode, Cortical
GYD
Transducer, Tremor
GYE
Encephalogram Telemetry System
GZK
Electrode, Nasopharyngeal
GZL
Electrode, Depth
GZM
Analyzer, Rigidity
GZN
Rheoencephalograph
GZO
Device, Galvanic Skin Response Measurement
GZP
Stimulator, Mechanical, Evoked Response
HCJ
Device, Skin Potential Measurement
HCS
Device, Temperature Measurement, Direct Contact, Powered
JXE
Device, Nerve Conduction Velocity Measurement
JXF
Plethysmograph, Ocular
LLN
Device, Vibration Threshold Measurement
LQW
Test, Temperature Discrimination
NCG
Neuropsychiatric Interpretative Electroencephalograph Assessment Aid
NTU
Evoked Potential Stimulator, Thermal
OLT
Non-Normalizing Quantitative Electroencephalograph Software
OLU
Normalizing Quantitative Electroencephalograph Software
OLV
Standard Polysomnograph With Electroencephalograph
OLW
Index-Generating Electroencephalograph Software
OLX
Source Localization Software For Electroencephalograph Or Magnetoencephalograph
OLY
Magnetoencephalograph
OLZ
Automatic Event Detection Software For Polysomnograph With Electroencephalograph
K
24
2094
Dreem 3S
K
23
3438
SleepStageML
K
22
3539
Dreem 3S
K
22
3922
SOMNUM (V.1.1.2.)
K
22
1179
SomnoMetry
K
21
0034
EnsoSleep
K
20
2142
Sleepware G3
K
19
2469
Nox Sleep System
K
18
2227
Esprit Nova
K
17
3366
NicoletOne
K
16
3617
REMbrandt
K
16
2627
EnsoSleep
K
16
2140
RemLogic
K
15
3353
SANDMAN ELITE
K
15
3412
Sleep Profiler
K
14
2988
Sleepware G3
K
14
2825
Zmachine
K
13
0007
SLEEP PROFILER
K
12
0450
SLEEP PROFILER
K
09
0277
NATUS SLEEPWORKS, MODEL 104017
K
06
2943
POLYSMITH SLEEP SYSTEM, MODEL NTI5498
K
04
0595
ALICE 5
K
00
2622
BIOSLEEP
K
96
3631
SLEEP STUDY ANALYSIS (SSA) VERSION 96.10
K
96
1636
MEDILOG VISION
K
91
5856
SENSORMEDICS 4000 SERIES SLEEP SYSTEM
K
89
4155
SLEEPSCAN
K
89
1383
MEDILOG 9200 EEG REPLAY/ANALYSIS SYSTEM
K
89
0513
SAC 747 AND SAC 847 (SLEEP ANALYZING COMPUTERS)
K
87
1990
MODEL MPA MULTI PARAMETER ANALYSIS MONITORING SYS.
K
86
2527
SLEEP ANALYZING COMPUTER
OMA
Amplitude-Integrated Electroencephalograph
OMB
Automatic Event Detection Software For Full-Montage Electroencephalograph
OMC
Reduced- Montage Standard Electroencephalograph
ORT
Burst Suppression Detection Software For Electroencephalograph
PIW
Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid
PKQ
Computerized Cognitive Assessment Aid
PNA
Evoked Photon Image Capture Device
POM
Computerized Cognitive Assessment Aid For Concussion
POP
Cranial Motion Measurement Device
POS
Physiological Signal Based Seizure Monitoring System
PSP
Intracranial Pressure & Temperature Monitoring Kit
PTB
Ataxiagraph With Interpretive Software
PTY
Computerized Cognitive Assessment Aid, Exempt
PVP
Neurological Test Kit
QEA
Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid
QPF
Pediatric Autism Spectrum Disorder Diagnosis Aid
OPT
Infrared Hematoma Detector
Subpart B—Physical Medicine Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart D—Physical Medicine Prosthetic Devices
Subpart E—Neurological Surgical 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
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
NE
/
subpart-b—neurological-diagnostic-devices
/
OLZ
/
K090277
View Source
NATUS SLEEPWORKS, MODEL 104017
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K090277
510(k) Type
Traditional
Applicant
EXCEL-TECH LTD. (XLTEK)
Country
Canada
FDA Decision
Substantially Equivalent
Decision Date
4/19/2011
Days to Decision
804 days
Submission Type
Statement