FDA Browser
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
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
24
0100
SAM Model 9-10000
2
Cleared 510(K)
K
23
1355
Aurora
2
Cleared 510(K)
K
23
1546
Somfit
2
Cleared 510(K)
K
22
3573
Onera Sleep Test System (Onera STS)
2
Cleared 510(K)
K
22
1816
Wesper Lab
2
Cleared 510(K)
K
22
2579
Belun Sleep System BLS-100
2
Cleared 510(K)
K
22
2950
AcuPebble OX100
2
Cleared 510(K)
K
22
3675
WatchPAT ONE (WP1)
2
Cleared 510(K)
K
22
0012
BresoDX1
2
Cleared 510(K)
K
22
2331
WatchPAT300 (WP300)
2
Cleared 510(K)
K
22
0095
ANNE Sleep
2
Cleared 510(K)
K
21
3360
SleepCheckRx
2
Cleared 510(K)
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)
K
19
1095
Maxxi Snore Sensor
2
Cleared 510(K)
K
19
1925
MATRx Plus
2
Cleared 510(K)
K
18
3625
SomnaPatch
2
Cleared 510(K)
K
18
0001
Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie, Disposable BreathSensor Infant
2
Cleared 510(K)
K
18
2618
SleepImage System
2
Cleared 510(K)
K
17
3974
DROWZLE
2
Cleared 510(K)
K
17
1304
Maxxi Rip Sensor
2
Cleared 510(K)
K
18
3559
WatchPAT ONE
2
Cleared 510(K)
K
17
3793
XactTrace Single Use Respiratory Effort Belt System
2
Cleared 510(K)
K
18
1996
MATRx Plus
2
Cleared 510(K)
K
18
0775
Watch-PAT300
2
Cleared 510(K)
K
17
2799
Positional Sleep Assessment System (PoSAS) software
2
Cleared 510(K)
K
16
3696
SleepImage System
2
Cleared 510(K)
K
16
3665
MATRx plus
2
Cleared 510(K)
K
16
0499
Apnea Risk Evaluation System (ARES), Model 620
2
Cleared 510(K)
K
16
1579
Watch-PAT200U
2
Cleared 510(K)
K
15
3070
Watch-PAT200U
2
Cleared 510(K)
K
15
1874
BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal
2
Cleared 510(K)
K
15
1433
AUDICOR CA300/CC100 Analyzer with SDB
2
Cleared 510(K)
K
15
1361
Nox RIP Belts & Cables
2
Cleared 510(K)
K
15
0102
SnoreSounds
2
Cleared 510(K)
K
14
3272
ApneaLink Air
2
Cleared 510(K)
K
14
0861
SOMNOTOUCH RESP
2
Cleared 510(K)
K
13
3859
WATCH-PAT200U (WP200U)
2
Cleared 510(K)
K
13
1883
AUDICOR CPAM WITH SDB (ACCELEROMETER BASED)
2
Cleared 510(K)
K
13
1932
APNEALINK PRO
2
Cleared 510(K)
K
13
1994
SOMNOLYZER 24X7
2
Cleared 510(K)
K
12
4062
QDC-PRO, AND NOX-RIP
2
Cleared 510(K)
K
12
2516
EMBLETTA MPR
2
Cleared 510(K)
K
11
2514
APNEA RISK EVALUATION SYSTEM (ARES)
2
Cleared 510(K)
K
11
2822
SLEEPSTRIP II
2
Cleared 510(K)
K
11
2102
MICHELE SLEEP SCORING SYSTEMS
2
Cleared 510(K)
K
11
1742
MDRIVE
2
Cleared 510(K)
K
11
1314
MORPHEUS OX
2
Cleared 510(K)
K
11
0486
ACCUSOM
2
Cleared 510(K)
K
11
1194
APNEA RISK EVALUATION SYSTEM (ARES)
2
Cleared 510(K)
K
10
2567
WATCH-PAT 200S-3 (WP200S-3)
2
Cleared 510(K)
K
11
0705
APNEA RISK EVALUATION SYSTEM (ARES)
2
Cleared 510(K)
K
11
0064
SNAP MODEL 8 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM
2
Cleared 510(K)
K
09
2003
CPC SLEEP DATA RECORDER, MODEL M1, AND APPLICATION SOFTWARE
2
Cleared 510(K)
K
09
0484
ALICE PDX
2
Cleared 510(K)
K
09
0958
INOMAX DS (DELIVERY SYSTEM)
2
Cleared 510(K)
K
08
2853
CLINICAL OXYGEN DOSE RECORDER (CODR), MODEL 300-CR
2
Cleared 510(K)
K
08
3575
APNEALINK PLUS, MODEL: 22328
2
Cleared 510(K)
K
08
3620
SOMNOLYZER 24X7
2
Cleared 510(K)
K
08
3874
GALAXY
2
Cleared 510(K)
K
08
2968
APNEICARE CONNECTION CENTER/INTERNET ANALYSIS
2
Cleared 510(K)
K
08
1861
HOLTER LX ANALYSIS
2
Cleared 510(K)
K
08
2113
NOX T3, NOXTURNAL (PC APPLICATION)
2
Cleared 510(K)
K
08
1485
SOMNOWATCH
2
Cleared 510(K)
K
08
0375
RMX PHYSIOLOGICAL DATA RECORDER
2
Cleared 510(K)
K
08
1982
WATCH-PAT 200S-2 (WP200S-2)
2
Cleared 510(K)
K
07
3682
EMBLETTA GOLD
2
Cleared 510(K)
K
08
0983
PROVENT NASAL CANNULA
2
Cleared 510(K)
K
08
1176
FLOCHANNEL
2
Cleared 510(K)
K
08
1037
WATCH-PAT 200I (WP200I)
2
Cleared 510(K)
K
08
0427
WATCH-PAT MODEL 100S-2
2
Cleared 510(K)
K
08
0321
SNAP MODEL 7 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM
2
Cleared 510(K)
K
07
3269
HC1000P SLEEP DIAGNOSIS SOFTWARE SYSTEM
2
Cleared 510(K)
K
07
2201
COMPUMEDICS SOMTE PSG RECORDING SYSTEM
2
Cleared 510(K)
K
07
0855
SLEEP QUALITY
2
Cleared 510(K)
K
07
2014
VITASCORE
2
Cleared 510(K)
K
07
1230
APNEA RISK EVALUATION SYSTEM (ARES), MODEL 600
2
Cleared 510(K)
K
07
1556
SOMNOSCREEN EEG10-20
2
Cleared 510(K)
K
07
0263
APNEALINK
2
Cleared 510(K)
K
07
0326
NOGA AUTOMATED SLEEP STUDY SCORING AND DATA MANAGEMENT SYSTEM
2
Cleared 510(K)
K
06
0708
SOMNOSCREEN
2
Cleared 510(K)
K
06
1705
CADWELL EASYNET NASAL PRESSURE MODULE
2
Cleared 510(K)
K
06
1996
SANDMAN POCKET
2
Cleared 510(K)
K
06
1764
MEDIBYTE, MODEL MP8
2
Cleared 510(K)
K
06
1405
APNEALINK, MODEL 22302
2
Cleared 510(K)
K
05
2573
STARDUST II
2
Cleared 510(K)
K
05
1313
BI-NAPS NASAL AIRFLOW AND SNORE TRANSDUCER
2
Cleared 510(K)
K
04
2745
LIFESCREEN APNEA
2
Cleared 510(K)
K
04
2916
WATCH PAT 100S
2
Cleared 510(K)
K
04
3132
UNIVERSAL XACTTRACE
2
Cleared 510(K)
K
04
1662
APNEA RISK EVALUATION SYSTEM (ARES)
2
Cleared 510(K)
K
04
2253
SLEEPSENSE SLEEP SENSORS
2
Cleared 510(K)
K
04
1724
COMPASS M10 SYSTEM
2
Cleared 510(K)
K
04
1904
COMPASS F10 SYSTEM
2
Cleared 510(K)
K
04
0576
MICROMESAM BASIC-SET
2
Cleared 510(K)
K
03
3402
PORTABLE SLEEP DATA RECORDER (PSDR)
2
Cleared 510(K)
K
02
1845
STARDUST II, MODEL 1011176
2
Cleared 510(K)
K
04
0069
DYMEDIX REUSABLE AIRFLOW/SNORE SENSOR
2
Cleared 510(K)
K
04
0194
COMPUMEDICS SUMMIT IP
2
Cleared 510(K)
K
02
4322
EMBLA N7000
2
Cleared 510(K)
K
03
0379
APLAB, MODEL 801D0030
2
Cleared 510(K)
K
02
2506
MORPHEUS 1, AUTOMATED SLEEP STUDY SCORING & DATA MANAGEMENT SYSTEM
2
Cleared 510(K)
K
02
2294
APNEACHECK
2
Cleared 510(K)
K
03
0611
MODIFICATION TO SUZANNE PORTABLE POLYSOMNOGRAPH SYSTEM
2
Cleared 510(K)
K
02
1138
SLEEPSCREEN/APNOESCREEN CARDIO
2
Cleared 510(K)
K
02
1176
COMPUMEDICS SOMTE SYSTEM
2
Cleared 510(K)
K
02
0607
SLEEPFLO, MODEL 101501
2
Cleared 510(K)
K
02
0312
ULTIMA SNORING MIKE, MODEL 0540
2
Cleared 510(K)
K
01
2437
DEVILBISS SLEEP RECORDER MODEL # RM60
2
Cleared 510(K)
K
00
2159
SNORE SAT RECORDER, MODEL SS41
2
Cleared 510(K)
K
01
0156
SLEEP PAT 200 DEVICE
2
Cleared 510(K)
K
01
3905
MODIFICATION EZ-1 SYSTEM REPIRATORY SENSORS
2
Cleared 510(K)
K
01
0739
WATCH-PAT 100
2
Cleared 510(K)
K
00
2095
SNAP MODEL 6
2
Cleared 510(K)
K
00
0396
APNOESCREEN PRO, ALPHA SCREEN PRO
2
Cleared 510(K)
K
00
2135
SLEEPSTRIP DISPOSABLE APNEA SCREENER
2
Cleared 510(K)
K
00
0253
SILENT NIGHT V
2
Cleared 510(K)
K
99
2322
SNAP MODEL 5
2
Cleared 510(K)
K
99
0565
SUZANNE
2
Cleared 510(K)
K
99
0321
ALPHAMED GEMINI SENSOR, SNORING SENSOR
2
Cleared 510(K)
K
98
4169
DIGI-SNAP
2
Cleared 510(K)
K
99
0199
SMARTRECORDER, MODEL 2500
2
Cleared 510(K)
K
98
3572
SIMON MULTICHANNEL RECORDING SYSTEM, MODEL 5500
2
Cleared 510(K)
K
98
1034
SILENT NIGHT II
2
Cleared 510(K)
K
98
2293
PRESSURE TRANSDUCER AIRFLOW SENSOR
2
Cleared 510(K)
K
97
3920
STARDUST
2
Cleared 510(K)
K
97
1803
NEUROTRONICS POLYSOMNOGRAPHY SYSTEM 101
2
Cleared 510(K)
K
97
1501
SLEEPSCAN AIRFLOW PRESSURE TRANSDUCER
2
Cleared 510(K)
K
97
1184
OXI-SNAP
2
Cleared 510(K)
K
95
5841
SLEEP SYSTEM FOR CLINICS & RESEARCH
2
Cleared 510(K)
K
96
4494
SLEEPWIZARD
2
Cleared 510(K)
K
96
3597
SILENT NIGHT I
2
Cleared 510(K)
K
96
2103
BIO-LOGIC SLEEPSCAN PRODUCT WITH BUILT-IN OXIMETER
2
Cleared 510(K)
K
94
4524
SNAP TESTING DEVICE
2
Cleared 510(K)
K
95
0273
SLEEP TEST(TM)
2
Cleared 510(K)
K
94
0013
BODY POSITION INDICATOR, MODEL BPI1
2
Cleared 510(K)
K
94
4611
MODEL# 7500 SURVEYOR
2
Cleared 510(K)
K
94
0015
SNORING MICROPHONE, SM1
2
Cleared 510(K)
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
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Dental
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Ear, Nose, Throat
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Gastroenterology and Urology
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General Hospital
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Hematology
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Immunology
Review Panel
Microbiology
Review Panel
Neurology
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Obstetrical and Gynecological
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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
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Review Panel
Last synced on 16 August 2024 at 11:05 pm
AN
/
subpart-c—monitoring-devices
/
MNR
/
K203343
View Source
Wesper Lab
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K203343
510(k) Type
Traditional
Applicant
Wesper Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/21/2021
Days to Decision
403 days
Submission Type
Summary
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)
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
24
0100
SAM Model 9-10000
K
23
1355
Aurora
K
23
1546
Somfit
K
22
3573
Onera Sleep Test System (Onera STS)
K
22
1816
Wesper Lab
K
22
2579
Belun Sleep System BLS-100
K
22
2950
AcuPebble OX100
K
22
3675
WatchPAT ONE (WP1)
K
22
0012
BresoDX1
K
22
2331
WatchPAT300 (WP300)
K
22
0095
ANNE Sleep
K
21
3360
SleepCheckRx
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
K
19
1095
Maxxi Snore Sensor
K
19
1925
MATRx Plus
K
18
3625
SomnaPatch
K
18
0001
Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie, Disposable BreathSensor Infant
K
18
2618
SleepImage System
K
17
3974
DROWZLE
K
17
1304
Maxxi Rip Sensor
K
18
3559
WatchPAT ONE
K
17
3793
XactTrace Single Use Respiratory Effort Belt System
K
18
1996
MATRx Plus
K
18
0775
Watch-PAT300
K
17
2799
Positional Sleep Assessment System (PoSAS) software
K
16
3696
SleepImage System
K
16
3665
MATRx plus
K
16
0499
Apnea Risk Evaluation System (ARES), Model 620
K
16
1579
Watch-PAT200U
K
15
3070
Watch-PAT200U
K
15
1874
BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal
K
15
1433
AUDICOR CA300/CC100 Analyzer with SDB
K
15
1361
Nox RIP Belts & Cables
K
15
0102
SnoreSounds
K
14
3272
ApneaLink Air
K
14
0861
SOMNOTOUCH RESP
K
13
3859
WATCH-PAT200U (WP200U)
K
13
1883
AUDICOR CPAM WITH SDB (ACCELEROMETER BASED)
K
13
1932
APNEALINK PRO
K
13
1994
SOMNOLYZER 24X7
K
12
4062
QDC-PRO, AND NOX-RIP
K
12
2516
EMBLETTA MPR
K
11
2514
APNEA RISK EVALUATION SYSTEM (ARES)
K
11
2822
SLEEPSTRIP II
K
11
2102
MICHELE SLEEP SCORING SYSTEMS
K
11
1742
MDRIVE
K
11
1314
MORPHEUS OX
K
11
0486
ACCUSOM
K
11
1194
APNEA RISK EVALUATION SYSTEM (ARES)
K
10
2567
WATCH-PAT 200S-3 (WP200S-3)
K
11
0705
APNEA RISK EVALUATION SYSTEM (ARES)
K
11
0064
SNAP MODEL 8 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM
K
09
2003
CPC SLEEP DATA RECORDER, MODEL M1, AND APPLICATION SOFTWARE
K
09
0484
ALICE PDX
K
09
0958
INOMAX DS (DELIVERY SYSTEM)
K
08
2853
CLINICAL OXYGEN DOSE RECORDER (CODR), MODEL 300-CR
K
08
3575
APNEALINK PLUS, MODEL: 22328
K
08
3620
SOMNOLYZER 24X7
K
08
3874
GALAXY
K
08
2968
APNEICARE CONNECTION CENTER/INTERNET ANALYSIS
K
08
1861
HOLTER LX ANALYSIS
K
08
2113
NOX T3, NOXTURNAL (PC APPLICATION)
K
08
1485
SOMNOWATCH
K
08
0375
RMX PHYSIOLOGICAL DATA RECORDER
K
08
1982
WATCH-PAT 200S-2 (WP200S-2)
K
07
3682
EMBLETTA GOLD
K
08
0983
PROVENT NASAL CANNULA
K
08
1176
FLOCHANNEL
K
08
1037
WATCH-PAT 200I (WP200I)
K
08
0427
WATCH-PAT MODEL 100S-2
K
08
0321
SNAP MODEL 7 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM
K
07
3269
HC1000P SLEEP DIAGNOSIS SOFTWARE SYSTEM
K
07
2201
COMPUMEDICS SOMTE PSG RECORDING SYSTEM
K
07
0855
SLEEP QUALITY
K
07
2014
VITASCORE
K
07
1230
APNEA RISK EVALUATION SYSTEM (ARES), MODEL 600
K
07
1556
SOMNOSCREEN EEG10-20
K
07
0263
APNEALINK
K
07
0326
NOGA AUTOMATED SLEEP STUDY SCORING AND DATA MANAGEMENT SYSTEM
K
06
0708
SOMNOSCREEN
K
06
1705
CADWELL EASYNET NASAL PRESSURE MODULE
K
06
1996
SANDMAN POCKET
K
06
1764
MEDIBYTE, MODEL MP8
K
06
1405
APNEALINK, MODEL 22302
K
05
2573
STARDUST II
K
05
1313
BI-NAPS NASAL AIRFLOW AND SNORE TRANSDUCER
K
04
2745
LIFESCREEN APNEA
K
04
2916
WATCH PAT 100S
K
04
3132
UNIVERSAL XACTTRACE
K
04
1662
APNEA RISK EVALUATION SYSTEM (ARES)
K
04
2253
SLEEPSENSE SLEEP SENSORS
K
04
1724
COMPASS M10 SYSTEM
K
04
1904
COMPASS F10 SYSTEM
K
04
0576
MICROMESAM BASIC-SET
K
03
3402
PORTABLE SLEEP DATA RECORDER (PSDR)
K
02
1845
STARDUST II, MODEL 1011176
K
04
0069
DYMEDIX REUSABLE AIRFLOW/SNORE SENSOR
K
04
0194
COMPUMEDICS SUMMIT IP
K
02
4322
EMBLA N7000
K
03
0379
APLAB, MODEL 801D0030
K
02
2506
MORPHEUS 1, AUTOMATED SLEEP STUDY SCORING & DATA MANAGEMENT SYSTEM
K
02
2294
APNEACHECK
K
03
0611
MODIFICATION TO SUZANNE PORTABLE POLYSOMNOGRAPH SYSTEM
K
02
1138
SLEEPSCREEN/APNOESCREEN CARDIO
K
02
1176
COMPUMEDICS SOMTE SYSTEM
K
02
0607
SLEEPFLO, MODEL 101501
K
02
0312
ULTIMA SNORING MIKE, MODEL 0540
K
01
2437
DEVILBISS SLEEP RECORDER MODEL # RM60
K
00
2159
SNORE SAT RECORDER, MODEL SS41
K
01
0156
SLEEP PAT 200 DEVICE
K
01
3905
MODIFICATION EZ-1 SYSTEM REPIRATORY SENSORS
K
01
0739
WATCH-PAT 100
K
00
2095
SNAP MODEL 6
K
00
0396
APNOESCREEN PRO, ALPHA SCREEN PRO
K
00
2135
SLEEPSTRIP DISPOSABLE APNEA SCREENER
K
00
0253
SILENT NIGHT V
K
99
2322
SNAP MODEL 5
K
99
0565
SUZANNE
K
99
0321
ALPHAMED GEMINI SENSOR, SNORING SENSOR
K
98
4169
DIGI-SNAP
K
99
0199
SMARTRECORDER, MODEL 2500
K
98
3572
SIMON MULTICHANNEL RECORDING SYSTEM, MODEL 5500
K
98
1034
SILENT NIGHT II
K
98
2293
PRESSURE TRANSDUCER AIRFLOW SENSOR
K
97
3920
STARDUST
K
97
1803
NEUROTRONICS POLYSOMNOGRAPHY SYSTEM 101
K
97
1501
SLEEPSCAN AIRFLOW PRESSURE TRANSDUCER
K
97
1184
OXI-SNAP
K
95
5841
SLEEP SYSTEM FOR CLINICS & RESEARCH
K
96
4494
SLEEPWIZARD
K
96
3597
SILENT NIGHT I
K
96
2103
BIO-LOGIC SLEEPSCAN PRODUCT WITH BUILT-IN OXIMETER
K
94
4524
SNAP TESTING DEVICE
K
95
0273
SLEEP TEST(TM)
K
94
0013
BODY POSITION INDICATOR, MODEL BPI1
K
94
4611
MODEL# 7500 SURVEYOR
K
94
0015
SNORING MICROPHONE, SM1
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
/
MNR
/
K203343
View Source
Wesper Lab
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K203343
510(k) Type
Traditional
Applicant
Wesper Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/21/2021
Days to Decision
403 days
Submission Type
Summary