FDA.reportPublic FDA data

Polysomnography analyser

Definition
A mains electricity (AC-powered) device designed to record and interpret a variety of physiologic functions during sleep to evaluate sleep/sleep-related disorders (e.g., insomnia, hypersomnia, apnoea). It typically performs electroencephalography, electrocardiography, electro-oculography, electromyography, and respiration, temperature, and pulse oximetry readings. It may also provide audiovisual information about the sleeping patient for behavioral analysis and other measurements (e.g., gastric reflux, bedwetting). The device includes electrodes, measuring instruments, samplers, filters, amplifiers, and appropriate software for processing data and providing patient diagnoses.
GUDID devices
423
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
08720256698296Onera STS 2Onera B.V.01.002026-05-15
08720256698302Onera STS 2Onera B.V.01.002026-05-15
08720256698319Onera STS 2Onera B.V.01.002026-05-15
08720256698326Onera STS 2Onera B.V.01.002026-05-15
08720256698333Onera STS 2Onera B.V.01.002026-05-15
08720256698340Onera STS 2Onera B.V.01.002026-05-15
08720256698357Onera STS 2Onera B.V.01.002026-05-15
08720256698364Onera STS 2Onera B.V.01.002026-05-15
08720256698371Onera STS 2Onera B.V.01.002026-05-15
08720256698463Onera STSOnera B.V.01.002026-05-15
08720256698487Onera STSOnera B.V.01.002026-05-15
08720256698494Onera STSOnera B.V.01.002026-05-15
08720256698500Onera STSOnera B.V.01.002026-05-15
08720256698517Onera STSOnera B.V.01.002026-05-15
08720256698524Onera STSOnera B.V.01.002026-05-15
08720256698531Onera STSOnera B.V.01.002026-05-15
10846446020304SomnostarCarefusion Corporation693292016-09-11
08720256698470Onera STS 2Onera B.V.01.002026-05-26
00606959055735Sleepware G3 Respironics, Inc.Sleepware G3 2026-01-22
10846446025392SomnostarCarefusion Corporation23469-0012016-09-13
10846446025422SomnostarCarefusion Corporation23586-0012016-09-13
10846446032598SomnostarCarefusion Corporation28484-0012016-09-13
10846446032604SomnostarCarefusion Corporation28483-0012016-09-13
10846446033243SomnostarCarefusion Corporation27187-0012016-09-13
10846446020076SomnostarCarefusion Corporation166102016-09-13
10846446020144SomnostarCarefusion Corporation169542016-09-13
00850015266706Sleep ProfilerADVANCED BRAIN MONITORING, INC.SP42-54022023-10-23
08720256698005Onera STSOnera B.V.01.002023-03-15
08720256698012Onera STSOnera B.V.01.002023-03-15
08720256698029Onera STSOnera B.V.01.002023-03-15
08720256698036Onera STSOnera B.V.01.002023-03-15
08720256698043Onera STSOnera B.V.01.002023-03-15
08720256698050Onera STSOnera B.V.01.002023-03-15
08720256698067Onera STSOnera B.V.01.002023-03-15
08720256698074Onera STSOnera B.V.01.002023-03-15
08720256698098Onera STSOnera B.V.01.002023-03-15
08720256698111Onera STSOnera B.V.01.002023-03-15
08720256698135Onera STSOnera B.V.01.002023-03-15
08720256698159Onera STSOnera B.V.01.002023-03-15
08720256698173Onera STSOnera B.V.01.002023-03-15
08720256698197Onera STSOnera B.V.01.002023-03-15
15694311111467Nox T3s SystemNox Medical ehf.NOX-T3S_USF2021-05-31
15694311111375Nox A1 SystemNox Medical ehf.NOX-A1PSG_USF2020-02-24
15694311110569Nox T3® System with WristOx2Nox Medical ehf.NOX-T3_USF2016-09-16
15694311110804Nox T3® Demo System with WristOx2Nox Medical ehf.NOX-T3D_USF2016-09-16
07290008986014SleepsenseS. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD12502016-09-20
07290008986021SleepsenseS. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD12002016-09-20
07290008986038SleepsenseS. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD13872016-09-20
07290008986045SleepsenseS. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD13882016-09-20
07290008986052SleepsenseS. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD13702016-09-20
07290008986083SleepsenseS. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD14012016-09-20
07290008986090SleepsenseS. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD 1401P 2016-09-20
07290008986120SleepsenseS. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD14172016-09-20
07290008986137SleepsenseS. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD14182016-09-20
07290008986144SleepsenseS. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD14002016-09-20
07290008986151SleepsenseS. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD14622016-09-20
07290008986243SleepsenseS. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD148302016-09-20
07290008986250SleepsenseS. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD148352016-09-20
07290008986274SleepsenseS. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD14836US2016-09-20
07290008986281SleepsenseS. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD15762016-09-20
07290008986304SleepsenseS. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD15782016-09-20
07290008986311SleepsenseS. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD17702016-09-20
07290008986328SleepsenseS. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD91022016-09-20
07290008986397SleepsenseS. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD91012016-09-20
07290008986502SleepsenseS. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDPS0162016-09-20
07290008986526SleepsenseSLP INC 1370-Kit 2016-09-20
07290008986533SleepsenseSLP INC 1388-Kit 2016-09-20
07290008986540SleepsenseSLP INC 1387-Kit 2016-09-20
07290008986601SleepsenseSLP INC 1770-Kit 2016-09-20
07290008986618SleepsenseSLP INC 1772-Kit 2016-09-20
07290008986632SleepsenseSLP INC 9101PTP-Kit 2016-09-20
07290008986694SleepsenseS. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD92012016-09-20
07290008986700SleepSenseS. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD12612016-08-10
07290008986717SleepsenseS. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD12622016-09-20
07290008986724SleepsenseS. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD12682016-09-20
07290008986731SleepsenseS. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD12692016-09-20
07290008986755SleepsenseS. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD12582016-09-20
07290008986779SleepsenseS. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD13892016-09-20
07290008986823SleepsenseS. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD13682016-09-20
07290008986830SleepsenseS. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD13692016-09-20