FDA.reportPublic FDA data

EnsoSleep

Primary DI
00864458000476
Brand
EnsoSleep
Company
Ensodata, Inc.
Model
8
Device description
Automated sleep study scoring and report generation by EnsoData
Published
2025-04-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OLZAutomatic Event Detection Software For Polysomnograph With Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLZAutomatic Event Detection Software For Polysomnograph With ElectroencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210034000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210034000EnsoSleepEnsodata, Inc.2021-06-16OLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00864458000476PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00864458000476008644580004768644580004760864458000476

GMDN Terms#

Term, Definition table
TermDefinition
Sleep disorder interpretive software, professional-onlyAn interpretive software program intended to be used exclusively by healthcare professionals to collect and analyse patient physiological data during sleep and publish reports to assist diagnosis of sleep disorders (e.g., insomnia, sleep apnoea). It is typically used as part of a polysomnography study using a wide range of data of [e.g., electrocardiogram (ECG), electroencephalogram (EEG), haemoglobin oxygen saturation (SpO2), chest wall motion, airflow, eye movement].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080743964
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00864458000469EnsoSleep PPG82025-04-14
00864458000452Celeste+82025-04-07
00864458000445EnsoSleep PPG7.02024-02-22
00864458000414EnsoSleep7.02024-02-23
00864458000407EnsoSleep01.12017-07-19
00864458000421EnsoTherapy6.02023-11-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860008953117NEATBrain Electrophysiology Laboratory Company, LLCOLZ2026-05-12
00850049266055WavebandBeacon Biosignals, Inc.OLZ2026-04-17
00850049266062WavebandBeacon Biosignals, Inc.OLZ2026-04-17
B566847020ZmachineGeneral SleepOLZ2026-04-16
00606959055735Sleepware G3 Respironics, Inc.OLZ2026-01-22
00817111021332PolysmithNeurotronics, LLCOLZ2025-09-23
15694311112099DeepRESPNox Medical ehf.OLZ2025-06-06
00817111021264Live View Panel Pro Version 2.0Neurotronics, LLCOLZ2024-05-09
00864458000414EnsoSleepEnsodata, Inc.OLZ2024-02-23
00850015266706Sleep ProfilerADVANCED BRAIN MONITORING, INC.OLZ2023-10-23
00817111021257Polysmith Version 12.2Neurotronics, LLCOLZ2022-12-28
B600700014Cerebra Sleep SystemCerebra Medical LtdOLZ2022-07-13
15694311111665Noxturnal US APPNox Medical ehf.OLZ2021-10-18
15694311111610Nox A1® EEG 5 Lead Gold Electrode CableNox Medical ehf.OLZ2021-09-07
15694311111627Nox A1® EEG Head Cable Nox Medical ehf.OLZ2021-09-07
15694311111566Nox A1s RecorderNox Medical ehf.OLZ2021-07-10
15694311111580Nox A1s SystemNox Medical ehf.OLZ2021-07-10
15694311111597Nox C1s KitNox Medical ehf.OLZ2021-07-10
15694311110682Nox A1 Starter Sensor Kit, AdultNox Medical ehf.OLZ2021-02-03
15694311110699Nox A1 Starter Sensor Kit, PediatricNox Medical ehf.OLZ2021-02-03
15694311111498Nox C1 Access PointNox Medical ehf.OLZ2021-02-03
15694311111504Nox C1 KitNox Medical ehf.OLZ2021-02-03
00627987257502Esprit NovaSignalitica IncOLZ2020-12-06
15694311110095Nox A1 Carry CaseNox Medical ehf.OLZ2020-04-27
15694311110453Nox A1 EEG 5 Lead Gold Electrode CableNox Medical ehf.OLZ2020-04-27
15694311110521Nox A1 EEG Head CableNox Medical ehf.OLZ2020-04-27
00817111021172Polysmith Version 12.0Neurotronics, LLCOLZ2020-04-01
15694311110019Noxturnal APPNox Medical ehf.OLZ2020-02-24
15694311110590Nox C1 Access PointNox Medical ehf.OLZ2020-02-24
15694311110903Nox A1 RecorderNox Medical ehf.OLZ2020-02-24