FDA.report

Sleep disorder interpretive software

Definition
An interpretive software program intended to collect and analyse patient physiological data during sleep and publish reports to assist a healthcare professional in the diagnosis of sleep disorders (e.g., insomnia, snoring, sleep apnoea) or to help evaluate treatment (e.g., positive airway pressure). It may be used as part of a complete polysomnography study using a wide range of data (e.g., electrocardiogram (ECG), electroencephalogram (EEG), haemoglobin oxygen saturation (SpO2), chest wall motion, airflow, eye movement), or as part of a home-based study using a more limited data set [e.g., photoplethysmography (PPG) and motion tracking].
GUDID devices
35
Last updated
2020-04-12 06:34:09

Related Product Codes

CodeDeviceSpecialtyClassDevices
OLVStandard Polysomnograph With ElectroencephalographNeurology221
OLZAutomatic Event Detection Software For Polysomnograph With ElectroencephalographNeurology27
GWQFull-Montage Standard ElectroencephalographNeurology23
MNRVentilatory Effort RecorderAnesthesiology22
GWLAmplifier, Physiological SignalNeurology21
OLTNon-Normalizing Quantitative Electroencephalograph SoftwareNeurology21

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
00817111021172Polysmith Version 12.0NEUROTRONICS, INC.12.02020-04-01
15694311110019Noxturnal APPNox Medical ehf.NOX-NOXTURNAL_APP2020-02-24
15694311111368Noxturnal PSG CDNox Medical ehf.NOX-NOXTPSG_CD2020-02-24
00382830023924XltekEmbla Systems Ltd41200822016-10-24
00382830043441XltekEmbla Systems Ltd0120012016-10-25
00382830043458XltekEmbla Systems Ltd0139742016-10-25
00382830043489XltekEmbla Systems Ltd12490142016-10-25
00382830043533XltekEmbla Systems Ltd42830002016-10-25
00817111020755Polysmith Version 9.0NEUROTRONICS, INC.9.02016-09-22
00864458000407EnsoSleepENSODATA, INC.01.12017-07-19
10846446032550SomnostarCarefusion Corporation28008-0012016-09-13
10846446032611SomnostarCarefusion Corporation28477-0012016-09-13
10846446033267SomnostarCarefusion Corporation27686-0012016-09-13
10846446033274SomnostarCarefusion Corporation28481-0012016-09-13
10846446066050SomnoStarCarefusion Corporation31759-0012017-08-10
00382830048484EmblaEmbla Systems Ltd0254062018-11-20
00817111020748Polysmith Version 10.0NEUROTRONICS, INC.10.02016-09-22
00817111020779Polysmith Version 11.0NEUROTRONICS, INC.11.02017-03-10
00817111020816Live View Panel Version 1.4NEUROTRONICS, INC.1.42017-10-05
00841983103131Polysmith Sleep SystemNIHON KOHDEN AMERICA, INC.A/ONEBED-SCORE-9X2016-09-24
00841983103148Polysmith Sleep SystemNIHON KOHDEN AMERICA, INC.A/ONEBED-SCORE-10X2016-09-24
00841983104008Polysmith Sleep SystemNIHON KOHDEN AMERICA, INC.A/ONEBED-SCORE-11X2017-05-24
10846446020274SomnostarCarefusion Corporation637342016-09-13
10846446021080SomnostarCarefusion Corporation7766122016-09-13
10846446025415SomnostarCarefusion Corporation23474-0012016-09-13
10846446031485SomnostarCarefusion Corporation22312-0012016-09-13
10846446032185SomnostarCarefusion Corporation23486-0012016-09-13
10846446032208SomnostarCarefusion Corporation26322-0012016-09-13
10846446032260SomnostarCarefusion Corporation637832016-09-13
10846446032628SomnostarCarefusion Corporation28482-0012016-09-13
10846446033250SomnostarCarefusion Corporation27188-0012016-09-13
10846446033328SomnostarCarefusion Corporation30862-0012016-09-23
10846446065046SomnostarCarefusion Corporation28009-0012016-09-23
15694311110255Noxturnal®Nox Medical ehf.NOX-NOXT_CD2016-09-16
B6005537160MICHELE SLEEP SCORING SYSTEMCerebra Medical Ltd12018-02-12