FDA.report

Polysomnograph

Definition
A mains electricity (AC-powered) device designed to record physiological signals from a sleeping patient to assess sleep disorders (e.g., insomnia, snoring or sleep apnoea). The device is typically computerized and usually records an electrocardiogram (ECG), electroencephalogram (EEG), chest wall motion, airflow at both the nose and the mouth, eye movements, haemoglobin oxygen saturation (SpO2) and electromyogram (EMG). Parameters may be added or omitted depending on the study being performed. The device includes multiple electrodes/sensors placed on the patient in specific areas as well as amplifiers and filters for recording.
GUDID devices
998
Last updated
2026-03-20 20:35:48

Related Product Codes

CodeDeviceSpecialtyClassDevices
MNRVentilatory Effort RecorderAnesthesiology2406
BZQMonitor, Breathing FrequencyAnesthesiology2385
OLVStandard Polysomnograph With ElectroencephalographNeurology2120
GWQFull-Montage Standard ElectroencephalographNeurology213
GXYElectrode, CutaneousNeurology212
LXJInteractive Rehabilitation Exercise DevicesPhysical Medicine212
OLZAutomatic Event Detection Software For Polysomnograph With ElectroencephalographNeurology212
CATCannula, Nasal, OxygenAnesthesiology14
IKDCable, ElectrodePhysical Medicine24
OUGMedical Device Data SystemGeneral Hospital13
KZMDevice, Muscle MonitoringPhysical Medicine22
QRSDevice For Sleep Apnea Testing Based On Mandibular MovementEar, Nose, Throat22
GWFStimulator, Electrical, Evoked ResponseNeurology21
LELDevice, Sleep AssessmentNeurology21

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
09342451002655Compumedics SomfitCOMPUMEDICS LIMITEDSomfit2026-03-12
09342451002662Compumedics SomfitCOMPUMEDICS LIMITEDSomfit Charger2026-03-12
09342451002747Compumedics FalconCOMPUMEDICS LIMITEDFalcon HST2026-03-12
09342451002754Compumedics FalconCOMPUMEDICS LIMITEDFalcon HST2026-03-12
09342451002785Compumedics FalconCOMPUMEDICS LIMITEDFalcon HST2026-03-12
09342451002822Compumedics SomfitCOMPUMEDICS LIMITEDSomfit2026-03-12
09342451002860Compumedics SomfitCOMPUMEDICS LIMITEDSomfit2026-03-12
09342451007063Compumedics Somfit DCOMPUMEDICS LIMITEDSomfit D2026-03-12
00840067104224CadwellCADWELL INDUSTRIES, INC.190306-200-COR2026-03-02
00840067104200CadwellCADWELL INDUSTRIES, INC.190306-200-TST2026-03-01
00840067104217CadwellCADWELL INDUSTRIES, INC.190306-200-LEG2026-03-01
00840067104132Cadwell BlueBirdCADWELL INDUSTRIES, INC.302501-200-0302025-12-31
00840067104156Cadwell BlueBirdCADWELL INDUSTRIES, INC.302501-200-0402025-12-31
00840067104170Cadwell BlueBirdCADWELL INDUSTRIES, INC.302501-200-0502025-12-31
07290109223575WatchPAT400ITAMAR MEDICAL LTDWatchPAT4002025-12-01
B140MDO0BRAEBON MediOXBraebon Medical CorporationMD-O2025-04-28
B140MDOK0BRAEBON MediByte Jr. KitBraebon Medical CorporationMDO-K2025-04-28
00382830023955NatusXLTEK20130012025-02-27
00382830023986NatusXLTEK20400012025-02-27
00382830026765NatusXLTEK14510802025-02-27
00382830027236NatusXLTEK14210802025-02-27
00382830027243NatusXLTEK14210812025-02-27
00382830027250NatusXLTEK14210912025-02-27
00382830059244NatusXLTEK0117822025-02-27
00382830059251NatusXLTEK20200112025-02-27
04250413410705Set for wireless PLM measurementSOMNOmedics AGNGA1132019-08-13
042504134107121 channel ECG sensor including body position and disposable electrodesSOMNOmedics AGNGS091S2019-08-13
00382830026758XltekXLTEK14510722024-11-04
00382830047470XltekXLTEK14210522024-11-04
00860007837029Wesper LabTatch Inc.WSWW-RE-K-N-V02-BLO2024-07-30
00382830026741XltekXLTEK14510702024-04-19
00382830027670XltekXLTEK41401202024-04-19
00382830057585XltekXLTEK14210002024-04-11
04250413410781SOMNO HD / ECO accessorySOMNOmedics GmbHNGA3102023-11-30
04250413410828SOMNOscreen ECO EEG 32SOMNOmedics GmbHNGN740U 2023-11-30
00860007837012Wesper LabTatch Inc.WSWW-RE-K-N-V01-GRD2023-08-31
04250413400522SOMNOscreen Plus accessorySOMNOmedics GmbHSEN614O2023-08-25
04250413400607SOMNOscreen Plus accessorySOMNOmedics GmbHSEN6132023-08-25
04250413400614SOMNOscreen Plus accessorySOMNOmedics GmbHSEN6142023-08-25
07290109223193Central Plus Sensor ITAMAR MEDICAL LTDCentral Plus Sensor 2023-03-13
07290109223223WatchPAT ONEITAMAR MEDICAL LTDWatchPAT ONE-M (Canada)2023-03-13
07290109223230WatchPAT ONE ITAMAR MEDICAL LTDWatchPAT ONE E (Canada)2023-03-13
07290109223254WatchPAT ONE ITAMAR MEDICAL LTDWatchPAT ONE (Canada)2023-03-13
07290109222486Watch-PAT300ITAMAR MEDICAL LTDWatch-PAT3002019-08-20
05430001896015SunriseSunrise12022-06-30
05430001896060SunriseSunrise12022-06-30
00840067103463CadwellCADWELL INDUSTRIES, INC.302562-200-00002022-03-15
00840067103937CadwellCADWELL INDUSTRIES, INC.302551-200-04002022-03-15
00840067103944CadwellCADWELL INDUSTRIES, INC.302553-200-00002022-03-15
00840067103142CadwellCADWELL INDUSTRIES, INC.302518-200-00002021-12-15
00840067103173CadwellCADWELL INDUSTRIES, INC.302519-200-90002021-12-15
00840067103203CadwellCADWELL INDUSTRIES, INC.302522-200-00202021-12-15
00840067103210CadwellCADWELL INDUSTRIES, INC.302522-200-00802021-12-15
00840067103234CadwellCADWELL INDUSTRIES, INC.302529-200-00802021-12-15
00840067103258CadwellCADWELL INDUSTRIES, INC.302539-200-10802021-12-15
00840067103265CadwellCADWELL INDUSTRIES, INC.302548-200-00802021-12-15
00840067103296CadwellCADWELL INDUSTRIES, INC.302549-200-10802021-12-15
00840067103302CadwellCADWELL INDUSTRIES, INC.302549-200-90802021-12-15
00840067103333CadwellCADWELL INDUSTRIES, INC.302555-200-00802021-12-15
00840067103371CadwellCADWELL INDUSTRIES, INC.302563-200-10242021-12-15
00840067103388CadwellCADWELL INDUSTRIES, INC.302565-200-90802021-12-15
00840067103395CadwellCADWELL INDUSTRIES, INC.302566-200-00802021-12-15
00840067103401CadwellCADWELL INDUSTRIES, INC.302567-200-90802021-12-15
00840067103418CadwellCADWELL INDUSTRIES, INC.302568-200-00802021-12-15
00840067103425CadwellCADWELL INDUSTRIES, INC.302569-200-00802021-12-15
00840067103432CadwellCADWELL INDUSTRIES, INC.302561-200-10782021-12-15
00840067103470CadwellCADWELL INDUSTRIES, INC.302570-200-90002021-12-15
00840067103678CadwellCADWELL INDUSTRIES, INC.302523-200-04002021-12-15
00840067103685CadwellCADWELL INDUSTRIES, INC.302523-200-05002021-12-15
00840067103692CadwellCADWELL INDUSTRIES, INC.302525-200-00002021-12-15
00840067103715CadwellCADWELL INDUSTRIES, INC.302515-200-02802021-12-15
00840067103722CadwellCADWELL INDUSTRIES, INC.302515-200-04802021-12-15
00840067103753CadwellCADWELL INDUSTRIES, INC.302516-200-04802021-12-15
00840067103760CadwellCADWELL INDUSTRIES, INC.302516-200-94802021-12-15
00840067103777CadwellCADWELL INDUSTRIES, INC.302524-200-02002021-12-15
00840067103791CadwellCADWELL INDUSTRIES, INC.302528-200-90802021-12-15
00840067103807CadwellCADWELL INDUSTRIES, INC.302529-200-00002021-12-15
00840067103821CadwellCADWELL INDUSTRIES, INC.302531-200-00802021-12-15
00840067103838CadwellCADWELL INDUSTRIES, INC.302549-200-00802021-12-15
00840067103852CadwellCADWELL INDUSTRIES, INC.302510-200-04802021-12-15